Transcript שקופית 1

FlowLine Bipore® Heparin
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Product Description
 FlowLine Bipore vascular graft
 heparin coating of inner surface
 medical device class III
 wall thickness: 0,4 mm (thin wall)
0,7 mm (standard wall)
length:
100 - 1000 mm
diameter:
5 - 10 mm
 helical PTFE-monofilament reinforcement
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Product Description
 guideline:
JOTEC FlowLine Bipore Heparin Xmm TW
 coating not visible
 shelf life: 2 years
 no resterilization
 nomenclature: i.e. 15TW6006S
FlowLine Bipore
Heparin
length
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
diameter
S: fully reinforced
N: no reinforcement
FlowLine Bipore® Heparin
Product Description
 additional label FlowLine Bipore Heparin
Heparin
covalent bonded
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Indications
Same indications as FlowLine Bipore®
 primarily in the periperal vascular region
- femoralpopliteal
- axillofemoral
- iliacoiliacal
- tibial and peroneal arteria
 arteriovenous shunt prothesis in hemodialysis
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Contraindications
 same contraindications as FlowLine Bipore®
 patients with hypersensitivity to heparin
HIT Type II (heparin-induced thrombocytopenia)
- immunologic disease
- activation of platelets in presence of heparin
- 0,5 - 3% of patients after dosage of 20.000 IU/d
- occurence within 20 days
- decrease of platelets < 50%
- thrombosis and bleeding
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Thrombocytopenia
 lower incidence of HIT Type II with porcine heparin than
with bovine heparin (0.4% vs 1.6%)
 dependent of applied heparin dose
Thrombocytopenia
(<50 000 / µl)
Thrombocytopenia
(<100 000 / µl)
Thrombotic
Complications
Full-Dose Heparin
(> 20.000 IU/d)
7/981 (0,7%)
26/1080 (2,4%)
4/1080 (0,4%)
Low-Dose Heparin
(< 15.000 IU/d)
0/362 (0%)
1/362 (0,3%)
no
Number of patients
Warketing T., Kelton J., Prog Hemost Thromb 10, 1-34, 1991
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Thrombocytopenia
Coating of FlowLine Bipore Heparin
 heparin from porcine intestinal mucosa
 release of at most 20 IU in the case of largest graft
no complications may be expected!
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Heparin in General
 physiological coagulation inhibitor
 liver, lung and intestinal mucosa
 physiological blood concentration: 100 µg/l
 enzymatic degradation by Heparinase
 half-life: 90 – 120 min
 partially excretion by urine
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Functional Principle
 binding of Antithrombin III in the blood plasma
inhibition of coagulation
 imitation of the antithrombotic effect of heparansulfate
as in the case of the natural endothelium
 creation of a „blood friendly“ surface by binding of
selected plasma proteins
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Established Heparin Coatings
Name
Producer
Market entry
Bonding
Application
Carmeda
BioActive
Surface®
Medtronic
1985
covalent
ECC, ventricular assist
devices, central
venous catheter,
coronary stent, ePTFE
vascular graft (Gore)
Duraflo II®
Baxter
1988
ionic
Bioline
Coating®
Jostra AG
1992
covalent
with ionic
interaction
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
ECC
ECC, centrifugal pump,
catheter, canules,
tubes
FlowLine Bipore® Heparin
Heparin Coating of Vascular Grafts
 InterVascular
InterGard™ Heparin
 W.L. Gore & Associates
GORE-TEX® PROPATEN Vascular Graft
 JOTEC
FlowLine Bipore® Heparin
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Product Comparison
Product name
InterGardTM
Heparin
GORE-TEX®
Propaten
FlowLine
Bipore®
Heparin
Material
Heparin
Polyester
porcine /
Collagen high molecular
Bonding
Registration
ionic
1991
ePTFE
porcine /
low molecular
covalent
2002
ePTFE
porcine /
high molecular
covalent
with ionic
interaction
2003
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Structural Comparison
InterGard™ Heparin
GORE-TEX® PROPATEN
ePTFE
Polyester
Collagen
Heparin +
Adhesive agent
Activated
surface
FlowLine Bipore® Heparin
Heparin
Adhesive
agent
ePTFE
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
Adhesive
agent
Heparin
FlowLine Bipore® Heparin
FlowLine Bipore® Heparin – Coating
ePTFE
–
Heparin
Covalent bonding
Adhesive agent
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
+
FlowLine Bipore® Heparin
InterGard™ Heparin – Coating
 ionic binding of high molecular heparin to polyester
 TDMAC (Tridodecyl-methyl-ammoniumchloride) as
adhesive agent
 impregnation of heparinized polyester graft with
collagen
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
InterGard™ Heparin
Just a fractional amount of
heparin in contact with
blood after implantation!
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
InterGard™ Heparin
 in vitro stability of heparin coating over 4 weeks with
minimal loss after 7 days
 prospektive randomized clinical trial in comparison to
uncoated ePTFE vascular graft
(Devine et al.J Vasc Surg 2001)
• lower amputation rate (6 vs 17)
• significantly higher patency rates
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
InterGard™ Heparin – Randomized Clinical Trial
Product brochure InterGard Heparin P/N: 7366/2
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
GORE-TEX® PROPATEN Vascular Graft – Coating
 heparin coating of ePTFE vascular grafts
• surface activation
• application of adhesive agent
• covalent binding of low molecular heparin by
end-point attachment
 interaction of active heparin sequences with circulating
blood
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
GORE-TEX® PROPATEN Vascular Graft
 stability proven in vitro – marginal heparin release within
24 h
 improved patency rates after 6 months (
Fig. 1)
• Test animal: dog
• Implantation site: Arteria carotis shunt model
• Ø: 3mm, length: no statement
 no thrombus formation on bioactive surface after
implantation for 2 h ( Fig. 2)
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
FlowLine Bipore® Heparin – Coating
 alternating coating consisting of adhesive agent and
high molecular heparin
high heparin loading to the inner surface!
 synthetic protein as adhesive agent
avoidance of toxic substances!
 covalent cross linking by EDC (carbodiimide)
avoidance of toxic substances!
 covalent bonding and ionic interactions
bioactive sequences freely accessible!
stable bonding of heparin!
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
FlowLine Bipore® Heparin – Coating
 no effect on the graft handling
• implantation technique
• anticoagulation
 no modification of mechanical features of ePTFE graft
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Dynamic Blood Test Using a Chandler Loop Model
ePTFE graft
Ø: 6 mm, l: 50 cm
37 °C
H.P. Wendel Clinical Research Laboratory,
Dept. of Thoracic and Cardiovascular Surgery,
University of Tübingen
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
blood: 18 ml
heparin: 1,2 IU/ml
contact time: 2h
FlowLine Bipore® Heparin
Dynamic Blood Test Using a Chandler Loop Model
Platelets [x103/µl]
C: Control
P: ePTFE graft
H: FlowLine Bipore®
Heparin
C
P
H
C
P
H
C
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
P
H
FlowLine Bipore® Heparin
Dynamic Blood Test Using a Chandler Loop Model
ePTFE graft after
2 hours of blood contact
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin after
2 hours of blood contact
FlowLine Bipore® Heparin
Comparison of Product Range JOTEC vs GORE-TEX
JOTEC Thin Wall,
w/o reinforcement
Length [cm]
Gore Thin Wall,
w/o reinforcement
Ø [mm] Catalogue-No.
40
5
15TW4005N
not available
50
6
7
8
15TW5006N
15TW5007N
15TW5008N
6
not available
8
80
6
7
8
15TW8006N
15TW8007N
15TW8008N
6
not available
8
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
Comparison of Product Range JOTEC vs GORE-TEX
JOTEC Thin Wall, reinforced
Gore Thin Wall, reinforced
Length [cm] Ø [mm] Catalogue-No.
40
5
15TW4005S
not available
50
6
7
8
15TW5006S
15TW5007S
15TW5008S
not available
not available
not available
70
5
15TW7005S
not available
6
80
6
7
8
15TW8006S
15TW8007S
15TW8008S
6
not available
8
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
JOTEC Product Range
Thin Wall
w/oreinforcement
Standard Wall
reinforced
w/o reinforcement
L [cm]
Ø [mm]
L [cm]
Ø [mm]
L [cm]
Ø [mm]
10
5
10
5
20
6
7
40
5
40
5
40
5
50
6
7
8
50
6
7
8
70
5
70
5
80
6
7
8
80
6
7
8
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
reinforced
L [cm]
Ø [mm]
-
-
50
6
7
8
50
6
7
8
70
5
-
-
80
6
7
8
-
-
FlowLine Bipore® Heparin
Product Advantages
 coating of inner surface
 no toxic substances
 stable covalent binding of heparin
 bioactive heparin sequences freely accessible
 high permanent hemocompatibility
 widest product spectrum
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
GORE-TEX® PROPATEN Vascular Graft
Product brochure GORE-TEX PROPATEN June 2002
Fig. 1
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net
FlowLine Bipore® Heparin
GORE-TEX® PROPATEN Vascular Graft
Product brochure GORE-TEX PROPATEN June 2002
Fig. 2
JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net