Transcript Document

EP SALES TRAINING
Blazer II XP™ Ablation Catheter
Blazer II XP™ Ablation Catheter
Agenda
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Blazer II XP™- Features
Atrial Flutter
Positioning
Brochure
Competition
Cabling Chart
Evaluation Model
How to Use
Generators Troubleshooting Guide
Clinical Evidence
Conclusion
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Blazer II XP™ Ablation Catheter
Features
Distal Segment
• Length & Curve Shape
• Performance
• Active Steering
Handle
• Tension Control
•Bi-wing Steering
•Handle Ergonomics
Tip Electrode
•Tip Size
•Cooling
•Temperature Sensor
Proximal Shaft
•Torqueability
•Pushability
•Trackability
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Blazer II XP™ & Blazer II XP™ HTD
Feature Summary
CATHETER FAMILY CONFIGURATIONS
DISTAL SHAFT
CHARACTERISTICS
Blazer II™
HTD
Blazer II XP™
Blazer II XP™
HTD
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Asymmetric
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Passive
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Exposed
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Imbedded
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Thermistor
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Blazer II™
Chilli II™
Tubing Lengths
Standard
Medium
Extended
Tubing Firmness
Standard Torque
High Torque
Curve Shapes
Small
Standard
Large
Cooling
Active
Tip Electrode
7f/4mm
8f/8mm Str
8f/8mm VM
Temperature Sensor
Thermocouple
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Blazer II XP™ Ablation Catheter
Atrial Flutter
Anatomy & Conduction
• Right Atrial Conduction
– Travels from SA node to the
AVNODE
• Flutter
– A re-entry circuit
– Classified as Typicial or Atypical
• Typical is circuit around right atrium
traveling counterclockwise and is
CTI dependent.
– Other forms include scar re-entry,
TV dependent, and LV dependent.
• Right Atrial Typical Flutter
• Ventricular response is slower due
to the AV node blocking some of
the circuits (i.e. 3:1)
• “Saw tooth” pattern on 12-lead
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Blazer II XP™ Ablation Catheter
Atrial Flutter
Ablating Flutter
• Dx placed in CS and around RA
– CS = to pace medially and
determine if origin is left or right
• Decapolar
– Around RA = confirm circuit is
counterclockwise
• Halo & Duo-Deca catheters
• Rx placed at TV
– Linear lesion from TV to IVC
through the Eustachian ridge
– Eustachian ridge very thick
requires deep lesion
– Rx typically used to confirm bidirectional block on either side of
ablation line.
• Halo or Duo-Deca does the same
thing.
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Blazer II XP™ Ablation Catheter
Atrial Flutter
Summary
• Symptoms
– Palpitations
– Dizziness
– Short of Breath
• Rhythm
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Narrow QRS
Variable conduction between the atrium and ventricle
Atrial cycle length of 200 - 250 msecs
Typical = counter clockwise around the right atrium
• Paroxysmal
– Initiates and terminates spontaneously
• Ablation
– Line from the TV to the IVC through the Eustachian
ridge
– Bi-directional block along with cycle lengths confirms
success
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Blazer II XP™ Ablation Catheter
Positioning
DISEASE
CATHETER
AVNRT
FLUTTER
AFIB
Blazer II
Blazer XP
CHILLI II
FLUTTER
CLINICAL REQUIREMENTS
CATHETER FEATURES
Deep lesion due to thick tissues in the RA between the IVC and TV (Eustachian 8f, 8mm --- 8f for RF heating area and 8mm for passive
Ridge)
cooling for higher power levels
Micromovement to create linear lesion from TV to IVC
Bi-Wing Steering Knob and Mechanical Steering
Mechanism
Stable tip contact throughout linear lesion
HTD Distal + Proximal tubing
Reach the TV
Normal Sized Hearts = Large Curve and for Enlarged
Hearts = Large Curve + Sheath (5890ST)
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Blazer II XP™ Ablation Catheter
Brochure
Clinical
Benefits
Technical
Info
POSITIONING
Ordering
Info
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Blazer II XP™ Ablation Catheter
Brochure
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Blazer II XP™ Ablation Catheter
Competition
COMPETITOR
PRODUCT
BSC SOLUTION
BARD
Stinger™ 8mm
Scorpion™
Blazer II XP™
Blazer II XP™
St Jude Medical / IBI
Therapy™ 8mm
Blazer II XP™
Livewire TC™ 8mm Blazer II XP™
Safire™
Blazer II XP™
Triflex™
─────
Biosense Webster
Johnson & Johnson
Celsius™ 8mm
Blazer II XP™
Medtronic
ContactR™ 8mm
ConductR™ 8mm
Blazer II XP™
Blazer II XP™
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Blazer II XP™ Ablation Catheter
Cabling Chart
Catheter can be connected to:
▪ EPT 1000XP™ generator
▪ Maestro 3000™ generator
▪ Stockert generator
▪ Osypka generator
▪ IBI generator (not in the chart,
model number 1684-TH
item 85864)
Blazer II XP™ (thermistor sensor)
cannot be used with Medtronic
generator ATAKR™.
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Blazer II XP™ Ablation Catheter
Evaluation Model
When preparing the evaluation of new customer please
follow the SIX easy steps outlined below:
STEP 1:
Schedule minimum 2 Flutter cases during the same day for
the evaluation.
STEP 2:
The evaluation is to be performed with Maestro 3000™
generator.
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Blazer II XP™ Ablation Catheter
Evaluation Model
STEP 3:
Suggest to the Physician to use high torque distal segment
for the superior performance. Depending on the physician
also mention we offer a standard torque distal segment which
is less traumatic
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Blazer II XP™ Ablation Catheter
Evaluation Model
STEP 4:
Suggest to Physician to use the Large Curve with a high
torque tubing, for added performance. If Physician is
accustomed to using a sheath, comment HTD should
eliminate this need but order a 5890ST just in case.
LARGE HEART
almost 80% of
FLUTTER
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Blazer II XP™ Ablation Catheter
Evaluation Model
FLUTTER EVALUATION CATHETER CHECKLIST
Product
Units
3
BLAZER XP
STEP 5:
Utilize the following
chart of part numbers to
identify ALL of the
components that you
should order for the
evaluation. DO NOT
FORGET TO
SCHEDULE 2
FLUTTER CASES!
Catheter
M004
EPT4500THK2 0
M004 EPT4500TH
0
Units
3
Cable
M004 651 0
M004 651 0
M004 5890ST 0
Soft Tip Sheath
1
M004 21000TC 0
2
M004 3536010 20
1
M004 21870T 0
5
M004 354 0
2
M004 653S 0
2
M004 613 0
1
ESI cable (42-04322)
1
ESI cable (42-04323)
2
ESI filter box # 7504452-001 before
pod
MAESTRO
Connect BSC to
NAVx
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Blazer II XP™ Ablation Catheter
Evaluation Model
STEP 6: Before doing the ablation make the test on
Maestro 3000™ - as described in the following slide.
The test must be done in order to verify the compatibility
of the generator with the recording system installed in
the cat lab.
Tester required.
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Blazer II XP™ Ablation Catheter
Evaluation Model
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Blazer II XP™ Ablation Catheter
How to Use
General Settings for FLUTTER:
Power
65-70w
Temperature
65-75°C
Time
120 sec
- Stop based on ECG
evaluation
- Drag lesions will need
multiple ON/OFF
Impedance
Max 120ohm
Fluro
6 o’clock on LAO view
ECG keys
Bidirectional isthmus block
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Blazer II XP™ Ablation Catheter
How to Use
Ablation Problem
High impedance:
• Char or coagulum on the catheter tip: wipe catheter
• Poor contact: need better reposition for better tip contact
Measured temperature BELOW Set Temperature
• Verify power settings
• Verify tip contact and measured impedance value
• Verify cable connections are not loose or faulty
Measured temperature ABOVE Set Temperature
• Transient measured above is acceptable
• Verify no coagulum
• Verify power settings
• Verify cable connections are not loose or faulty
• Turn OFF/ON generator to verify proper function
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Blazer II XP™ Ablation Catheter
How to Use
Ablation Problem
Measured Power BELOW Set Power
• Verify power and temperature settings
• Verify cable connections are not loose or faulty
Noisy Signals during ablation
• Verify amplification, clipping and filtering parameters of recording
machine are properly set.
• Verify cable connections are not loose or faulty
• Verify generator on separate electric circuit from recording machine
• Disconnect and turn off non-essential equipment.
• Verify tip electrode is clean.
• Consider changing APM or POD
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Maestro 3000™
Troubleshooting Guide
11 error codes exist.
Here listed meaning
& solution.
Brochure available.
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Blazer II XP™ Ablation Catheter
Clinical Evidence
Blazer II XP™ - Clinical study for FDA approval
“Radiofrequency catheter ablation of type 1 atrial flutter using large-tip
8- or 10-mm electrode catheters and a high-output radiofrequency
energy generator: results of a multicenter safety and efficacy study.”
Feld G, et Al.
UCSD Medical Center, University of California, San Diego, USA.
Blazer II XP™ (8mm and 10mm) was used in order to determine the
safety and efficacy in the treatment of atrial flutter.
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Blazer II XP™ Ablation Catheter
Clinical Evidence
Blazer II XP™ - Clinical study for FDA approval
250th patient enrolled
21 active sites
Max number of cases per site 30
Product Usage (n=284)
 8mm straight: 40%
 10mm straight: 50%
 8mm contour: 10%
Technique
Success Rates:
Acute: 94%
Recurrence rate (6 months):
4%
Adverse Event Rates
Major: 8%
Curve Usage (n=219)
 Asymmetrical (N4): 10%
 Large (K2): 70%
 Standard: 20%
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Blazer II XP™ Ablation Catheter
Clinical Evidence
FLUTTER Publications:
“Effect of isthmus anatomy and ablation catheter on
radiofrequency catheter ablation of the cavotricuspid
isthmus.”
Da Costa A, et Al.
University Hospital Jean Monnet, Saint-Etienne, France.
Circulation. 2004 Aug 31;110(9):1030-5.
PRODUCT
SUCCESS RATES
NUMBER OF PATIENTS
Blazer II XP™ 8mm tip
97%
123
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Blazer II XP™ Ablation Catheter
Clinical Evidence
FLUTTER Publications:
“Use of different catheter ablation technologies for
treatment of typical atrial flutter: acute results and long-term
follow-up.”
Marrouche NF, et Al.
Cleveland Clinic Foundation,Cleveland,USA.
Pacing Clin Electrophysiol. 2003 Mar;26(3):743-6.
PRODUCT
SUCCESS RATES
NUMBER OF PATIENTS
 Biosense-Webster 8-mm-tip
 Blazer II XP™ 10-mm tip
100%
25
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Blazer II XP™ Ablation Catheter
Clinical Evidence
FLUTTER Publications:
“Prospective randomized comparison of closed cooled-tip
versus 8-mm-tip catheters for radiofrequency ablation of
typical atrial flutter.”
Schreieck J, et Al.
Deutsches Herzzentrum Munchen and 1. Medizinische
Klinik, Munich, Germany.
Cardiovasc Electrophysiol. 2002 Oct;13(10):980-5
PRODUCT
SUCCESS RATES
NUMBER OF PATIENTS
Blazer II XP™ 8mm tip
98%
50
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Blazer II XP™ Ablation Catheter
Clinical Evidence
FLUTTER Publications:
Is 8-mm more effective than 4-mm tip electrode catheter for
ablation of typical atrial flutter?
Tsai, et Al.
National Yang-Ming University, School of Medicine, and
Veterans General Hospital-Taipei, Taiwan.
Circulation. 1999 Aug 17;100(7):768-71.
PRODUCT
SUCCESS RATES
NUMBER OF PATIENTS
Blazer II XP™ 8mm tip
92%
50
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Blazer II XP™ Ablation Catheter
Conclusion
Blazer II XP
Positioning
Clinical
Needs
•Deep Lesion
•Linear Ablation
Flutter
•Tip Contact
•Reach Anatomy
Catheter
Features
•8f/8mm Tip
Electrode
•Bi-wing knob and
mechanical steering
•HT distal and
proximal tubings
•Large Curve
Customer
Evaluation
•Min 2 AFL Cases
•BSC Generator
•Straight or VM Tip?
•STD or HT Distal?
•K2 or STD Curve?
•Order per List
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