Slide 1

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 2

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 3

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 4

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 5

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 6

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 7

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 8

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 9

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 10

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 11

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 12

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 13

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 14

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you


Slide 15

Neurostimulation
For Failed Back Surgery Syndrome
Literature Review Summary

Background
•

The most common use of SCS in the United States is for controlling the
pain associated with failed back surgery syndrome (FBSS).

•

FBSS occurs in patients who have typically undergone multiple
lumbosacral spine operations for conditions such as disk herniation,
lumbar stenosis, or spinal instability.1,2,3,4

•

The majority of patients with FBSS have radicular pain in one or both
legs, and many patients also have axial lower back pain.2

•

This literature review summary highlights results of studies to
demonstrate the clinical and cost-effectiveness of SCS for FBSS.

2 | MDT Confidential

Effectiveness Study
Kumar K, et al. 20071
Figure 1

•

Prospective, randomized, controlled
multicenter study of 100 FBSS patients
randomized to conventional medical
management (CMM) with or without
SCS.

•

At 6 months, 48% (24/50) of SCS
patients and 9% (4/43) of CMM patients
achieved the primary outcome of ≥ 50%
leg pain relief.

•

SCS group had significantly greater
health-related quality of life (HRQoL)
(P < 0.02) (Figure 1) and functional
capacity (P < 0.001) (Figure 2).

•

Figure 2

At 12 months, as-treated analysis found
that 48% of SCS patients and 18% of
CMM patients achieved ≥ 50% leg pain
relief (P = 0.03).

3 | MDT Confidential

Effectiveness Study
North RB, et al. 20055

•

Prospective, randomized, controlled
study of 50 FBSS patients who had
been selected for repeat lumbosacral
spine surgery. Patients were
randomized to SCS or re-operation.

•

At a mean follow-up of 2.9 years, 47% of
SCS patients and 12% of re-operation
patients reported ≥ 50% pain relief and
satisfaction with treatment (P < 0.01).

•

Use of narcotics was significantly less in
SCS patients, in that use was stable or
decreased in 87% compared to 58% in
re-operation patients (P < 0.025).

4 | MDT Confidential

Effectiveness Studies
Kumar K, et al. 20066 and Leveque J-C, et al. 20016

•

Retrospective study of 410 SCS
patients, of which 220 were FBSS
patients. At a mean follow-up period of
97.6 months, 60% (132/184) of
implanted patients had ≥ 50% pain
relief.2

•

Retrospective study of 30 FBSS
patients; 16 had permanent SCS
system implantation. At a median
follow-up of 34 months, 75% (12/16) of
implanted patients said that they were
continuing to experience ≥ 50% pain
relief.6

5 | MDT Confidential

Effectiveness Studies
Dario A, et al. 20017 and Ohnmeiss DD, et al. 20018

•

Prospective study of 49 FBSS patients, of
which 24 were SCS candidates. At a
mean follow-up of 42 months, 91%
(21/23) of implanted patients continued to
have “good results.”7

•

Retrospective study of 41 consecutive
SCS candidates with chronic, intractable
low back pain (mainly FBSS). At followup, which ranged from 5.5 to 19 months,
70% (21/36) of implanted patients said
they were satisfied with SCS outcome,
76% said they would have SCS again,
and 79% said they would recommend
SCS to someone else.8

6 | MDT Confidential

Additional Effectiveness Studies

Citation

Design and
Population

Devulder J,
et al. 19973

Retrospective,
69 FBSS patients

At average 4.9 years, 43 (62%) were still using SCS with “good pain relief.” 11 of the 43 patients had
returned to work. 14 used no analgesics, 11 used nonopiates, 16 used “weak” opiates, and 2 used “strong
opiates.”

Rainov NG,
et al. 19969

Prospective,
32 FBSS patients

At 2-3.5 years follow-up, 86% (25/29) of implanted patients reported “stable analgesia and good
outcome.” Through reduced pain and greatly diminished analgesic and neuroleptic use, all patients
regained QoL.

Fiume D,
et al. 199510

Retrospective,
55 FBSS patients

At mean 55 months follow-up, 56% (19/34) of implanted patients were classified as having a successful
response. At baseline, 91% were taking major analgesics and 9% were taking minor analgesics. At
follow-up, analgesia use was: 29% none, 35% minor, 35% major. 36% of patients who had been unable
to work before SCS were able to resume and stay working.

De La Porte C,
et al. 199311

Retrospective study
of 78 consecutive
FBSS patients

At mean 4 years follow-up, 55% (35/64) of implanted patients reported > 50% pain relief and 53% were
satisfied with outcome. At latest follow-up, 45% were taking no medications compared to 18% on
admission. 61% reported significant increase in daily activities, and 22% had returned to work.

North RB,
et al. 199112

Retrospective study
of 53 consecutive
FBSS patients

At average 2.2 years follow-up, 53% of patients were successes. At 5 years follow-up, 47% were
successes. At baseline, 74% used narcotic analgesics vs. 12% at last follow-up. Most patients reported
improvement in activities. Of 40 patients disabled before SCS, 10 had returned to work at last follow-up.

Outcomes

7 | MDT Confidential

Cost Study
North RB, et al. 200713

•

Hospital and professional charge
data (1991-1995 US$) on 40/50
patients in the randomized trial of
the effectiveness of SCS vs. reoperation.5

•

Mean cost per patient for intention
to treat (ITT) was $31,530 for SCS
and $38,160 for re-operation.

•

SCS was more dominant (more
effective and less expensive) than
re-operation in incremental costeffectiveness and cost-utility
ratios.

Intention-to-Treat Cost-effectiveness Plane

This ITT bootstrap simulation for incremental costs and QALYs
shows that 59% of results fall in the lower right-hand plane.
This finding demonstrates that SCS is more effective and less
costly compared to re-operation. Further, approximately 72% of
results fall below the cost-effectiveness threshold ($40,000)
routinely used by US health policy makers.

8 | MDT Confidential

Cost Study
Taylor RJ, et al. 200514
•

Decision-analytic and Markov model to
assess SCS for FBSS relative to
conventional medical management
(CMM).*

•

The 2-year base case cost for SCS was
16,250€ vs. 13,248€ for CMM, giving an
incremental cost of 3,002€ for SCS.
Incremental utility for SCS was 0.066
QALYs per patient.

•

The lifetime base cost for an average
patient was 75,758€ for SCS vs.
122,725€ for CMM, giving an incremental
cost of 46,967€ for CMM. Incremental
utility for SCS was 1.12 QALYs per
patient.

* Based

on economic study of SCS for FBSS by Kumar, et al. Health care costs were converted from
Canadian dollars at year 2000 prices to Euros at Year 2003 prices, based on both purchasing parity and
health care cost inflation in the European Union. Costs were discounted at 6%.

9 | MDT Confidential

Additional Cost Studies
Kumar K, et al. 200615 and Kumar K, et al. 200216 and Bell GK., et al. 199717
•

Calculated actual health care costs (2005
Canadian$) for SCS and its complications
in 160 consecutive patients. Mean cost of
SCS implant was $23,205 with $3,609 in
maintenance costs per year for an
uncomplicated case.15

•

Calculated actual 5-year health care costs
(2000 Canadian$) for 60 FBSS patients
with SCS matched to 44 with CMM. Mean
5-year cost for SCS was $29,123 per
patient vs. $38,029 per patient for CMM.
SCS was cost-effective after 2.5 years.16

•

5-year health care cost model (1994 US$)
for two identical FBSS patients, one with
SCS and one with back surgery. 5-year cost
for SCS was $80,000 on a charges basis
vs. $82,630 for surgery. For the patient
who passes the SCS trial and for whom
SCS is effective, SCS pays for itself within
2.1 years.17
10 | MDT Confidential

Summary
•

In all referenced clinical studies,1-3,5-12 including two RCTs, SCS was effective
in controlling the pain of FBSS long-term. SCS has been associated with
substantial reduction in medication3,5,10,11 and significant increases in activities
of daily living.1,7,11 Five studies found that SCS enabled return to work for an
average of 27% of patients (range 22-36%).3,7,10-12

•

The most frequent complication of SCS has been electrode migration
(2-18%).1,10-12 Electrode breakage from earlier studies9-12 did not occur in later
studies.1,3,6,8 In five studies, 6-15% of patients developed infection.6-7,10-12
Various complications have also led to surgical revision of pulse generator,
lead and/or system explantation.

•

Cost studies showed that mean first-year cost becomes substantially less in
the second year.

11 | MDT Confidential

Conclusions
•

The long-term clinical studies that are summarized have shown that SCS is
effective in controlling pain associated with FBSS, providing ≥ 50% relief in
48-91% of the patients among these studies.

•

Two economic studies indicated that as compared to CMM, SCS should
become cost-effective after about 2 years.16,17

12 | MDT Confidential

Neurostimulation Therapy for Chronic Pain
Truck and/or Limbs: Product manuals must be reviewed prior to use for detailed disclosure.

Indications:
Implantable neurostimulation systems: A Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) system as an aid in the
management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with the following conditions: Failed Back
Syndrome (FBS) or low back syndrome or failed back, radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk,
postlaminectomy pain, multiple back operations, unsuccessful disk surgery, degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, Complex Regional Pain Syndrome (CRPS), Reflex
Sympathetic Dystrophy (RSD), or causalgia.
Contraindications:
Diathermy: Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted
electrodes, resulting in severe injury or death.
Warnings: Sources of strong electromagnetic interference (e.g., defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact
with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes
to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device
(e.g., pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the
cardiac device.
Precautions: The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or
delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions
provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not
scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other
activities may cause shocking or jolting.
Adverse Events: Adverse events may include undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma,
epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief,
chest wall stimulation, and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.
Rx only

13 | MDT Confidential

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.

16.
17.

Kumar K, Taylor R, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized
controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2):179-188.
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year
experience. Neurosurgery. 2006;58:481-496.
Devulder J, De Laat M, Van Bastelaere M, Rolly G. Spinal cord stimulation: a valuable treatment for chronic failed back surgery patients. J Pain Symptom
Manage. 1997;13:296-301.
Heidecke V, Rainov NG, Burket W. Hardware failures in spinal cord stimulation for failed back surgery syndrome. Neuromodulation. 2000;3:27-30.
North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain; a randomized, controlled
trial. Neurosurgery. 2005;56:98-107.
Leveque J-C, Villavicencio AT, Bulsara KR, et al. Spinal cord stimulation for failed lower back surgery syndrome. Neuromodulation. 2001;4:1-9.
Dario A, Fortini G, Bertollo D, et al. Treatment of failed back surgery syndrome. Neuromodulation. 2001;4:105-110.
Ohnmeiss DD, Rashbaum RF. Patient satisfaction with spinal cord stimulation for predominant complaints of chronic, intractable low back pain. Spine J.
2001;1:358-363.
Rainov NG, Heidecke V, Burkert W. Short test-period spinal cord stimulation for failed back surgery syndrome. Minim Invasive Neurosurg. 1996;39:41-44.
Fiume D, Sherkat S, Callovini GM, et al. Treatment of failed back syndrome due to lumbo-sacral epidural fibrosis. Acta Neurochir. 1995(Suppl);64:116-118.
De La Porte C,Van de Kelft E. Spinal cord stimulation in failed back surgery syndrome. Pain. 1993;52:55-61.
North RB, Ewend MG, Lawton MT, et al. Failed back surgery syndrome: 5-year follow-up after spinal cord stimulator implantation. Neurosurgery. 1991;28:692699.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost-effectiveness and cost utility analysis
based on a randomized, controlled trial. Neurosurgery. 2007;61:361-369.
Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess
Health Care. 2005;21:351-358.
Kumar K, Wilson JR, Taylor RS, Gupta S. Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact. J Neurosurg Spine.
2006;5:19-203.
Kumar K, Malik S, Demeria D, et al. Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
Neurosurgery. 2002;51:106-116.
Bell GK, Kidd D, North RB. Cost-effective analysis of spinal cord stimulation in treatment of failed back surgery syndrome. J Pain Symptom Manage.
1997;13:28-295.

14 | MDT Confidential

200805141a

Thank you