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Product Description FlowLine Bipore vascular graft heparin coating of inner surface medical device class III wall thickness: 0,4 mm (thin wall)

Published byTerrence Lamper Modified over 9 years ago

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Presentation on theme: "Product Description FlowLine Bipore vascular graft heparin coating of inner surface medical device class III wall thickness: 0,4 mm (thin wall)"— Presentation transcript:

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2 Product Description FlowLine Bipore vascular graft heparin coating of inner surface medical device class III wall thickness: 0,4 mm (thin wall) ,7 mm (standard wall) length: mm diameter: mm helical PTFE-monofilament reinforcement

3 guideline: JOTEC FlowLine Bipore Heparin Xmm TW coating not visible
Product Description guideline: JOTEC FlowLine Bipore Heparin Xmm TW coating not visible shelf life: 2 years no resterilization nomenclature: i.e. 15TW6006S S: fully reinforced N: no reinforcement length FlowLine Bipore Heparin diameter

4 Heparin Product Description additional label FlowLine Bipore Heparin
covalent bonded

5 Indications Same indications as FlowLine Bipore® primarily in the periperal vascular region femoralpopliteal axillofemoral iliacoiliacal tibial and peroneal arteria arteriovenous shunt prothesis in hemodialysis

6 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 IU/d occurence within 20 days decrease of platelets < 50% thrombosis and bleeding

7 Thrombotic Complications
Thrombocytopenia lower incidence of HIT Type II with porcine heparin than with bovine heparin (0.4% vs 1.6%) dependent of applied heparin dose Number of patients Thrombocytopenia (< / µl) (< / µl) Thrombotic Complications Full-Dose Heparin (> IU/d) 7/981 (0,7%) 26/1080 (2,4%) 4/1080 (0,4%) Low-Dose Heparin (< IU/d) 0/362 (0%) 1/362 (0,3%) no Warketing T., Kelton J., Prog Hemost Thromb 10, 1-34, 1991

8 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!

9 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

10 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

11 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 ECC Bioline Coating® Jostra AG 1992 covalent with ionic interaction ECC, centrifugal pump, catheter, canules, tubes

12 Heparin Coating of Vascular Grafts
InterVascular InterGard™ Heparin W.L. Gore & Associates GORE-TEX® PROPATEN Vascular Graft JOTEC FlowLine Bipore® Heparin

13 Product Comparison Product name Material Heparin Bonding Registration
InterGardTM Heparin Polyester Collagen porcine / high molecular ionic 1991 GORE-TEX® Propaten ePTFE porcine / low molecular covalent 2002 FlowLine Bipore® Heparin porcine / high molecular covalent with ionic interaction 2003

14 Structural Comparison
InterGard™ Heparin GORE-TEX® PROPATEN ePTFE Polyester Collagen Heparin + Adhesive agent Activated surface Adhesive agent Heparin FlowLine Bipore® Heparin Heparin Adhesive agent ePTFE

15 FlowLine Bipore® Heparin – Coating
ePTFE Adhesive agent Heparin Covalent bonding + –

16 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

17 InterGard™ Heparin Just a fractional amount of heparin in contact with blood after implantation!

18 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

19 InterGard™ Heparin – Randomized Clinical Trial
Product brochure InterGard Heparin P/N: 7366/2

20 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

21 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)

22 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!

23 FlowLine Bipore® Heparin – Coating
no effect on the graft handling • implantation technique • anticoagulation no modification of mechanical features of ePTFE graft

24 Dynamic Blood Test Using a Chandler Loop Model
ePTFE graft Ø: 6 mm, l: 50 cm blood: 18 ml heparin: 1,2 IU/ml contact time: 2h H.P. Wendel Clinical Research Laboratory, Dept. of Thoracic and Cardiovascular Surgery, University of Tübingen

25 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 P H

26 Dynamic Blood Test Using a Chandler Loop Model
ePTFE graft after 2 hours of blood contact FlowLine Bipore® Heparin after 2 hours of blood contact

27 Comparison of Product Range JOTEC vs GORE-TEX
JOTEC Thin Wall, w/o reinforcement Gore Thin Wall, w/o reinforcement Length [cm] Ø [mm] Catalogue-No. 40 5 15TW4005N not available 50 6 7 8 15TW5006N 15TW5007N 15TW5008N 6 not available 8 80 15TW8006N 15TW8007N 15TW8008N

28 not available not available not available
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 15TW7005S not available 6 80 15TW8006S 15TW8007S 15TW8008S 6 not available 8

29 JOTEC Product Range Thin Wall Standard Wall w/oreinforcement
reinforced w/o reinforcement L [cm] Ø [mm] 10 5 20 6 7 40 - 50 6 7 8 70 80

30 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

31 GORE-TEX® PROPATEN Vascular Graft
Product brochure GORE-TEX PROPATEN June 2002 Fig. 1

32 GORE-TEX® PROPATEN Vascular Graft
Product brochure GORE-TEX PROPATEN June 2002 Fig. 2

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