5IndicationsSame indications as FlowLine Bipore®primarily in the periperal vascular regionfemoralpoplitealaxillofemoraliliacoiliacaltibial and peroneal arteriaarteriovenous shunt prothesis in hemodialysis
6same contraindications as FlowLine Bipore® patients with hypersensitivity to heparinHIT Type II (heparin-induced thrombocytopenia)immunologic diseaseactivation of platelets in presence of heparin0,5 - 3% of patients after dosage of IU/doccurence within 20 daysdecrease of platelets < 50%thrombosis and bleeding
7Thrombotic Complications Thrombocytopenialower incidence of HIT Type II with porcine heparin than with bovine heparin (0.4% vs 1.6%)dependent of applied heparin doseNumber of patientsThrombocytopenia(< / µl)(< / µl)Thrombotic ComplicationsFull-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%)noWarketing T., Kelton J., Prog Hemost Thromb 10, 1-34, 1991
8ThrombocytopeniaCoating of FlowLine Bipore Heparinheparin from porcine intestinal mucosarelease of at most 20 IU in the case of largest graftno complications may be expected!
9Heparin in Generalphysiological coagulation inhibitorliver, lung and intestinal mucosaphysiological blood concentration: 100 µg/lenzymatic degradation by Heparinasehalf-life: 90 – 120 minpartially excretion by urine
10Functional Principlebinding of Antithrombin III in the blood plasma inhibition of coagulationimitation of the antithrombotic effect of heparansulfate as in the case of the natural endotheliumcreation of a „blood friendly“ surface by binding of selected plasma proteins
12Heparin Coating of Vascular Grafts InterVascularInterGard™ HeparinW.L. Gore & AssociatesGORE-TEX® PROPATEN Vascular GraftJOTECFlowLine Bipore® Heparin
13Product Comparison Product name Material Heparin Bonding Registration InterGardTM HeparinPolyesterCollagenporcine / high molecularionic1991GORE-TEX® PropatenePTFEporcine / low molecularcovalent2002FlowLine Bipore® Heparinporcine / high molecularcovalent with ionic interaction2003
16InterGard™ Heparin – Coating ionic binding of high molecular heparin to polyesterTDMAC (Tridodecyl-methyl-ammoniumchloride) as adhesive agentimpregnation of heparinized polyester graft with collagen
17InterGard™ HeparinJust a fractional amount of heparin in contact with blood after implantation!
18InterGard™ Heparinin vitro stability of heparin coating over 4 weeks with minimal loss after 7 daysprospektive 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
20GORE-TEX® PROPATEN Vascular Graft – Coating heparin coating of ePTFE vascular graftssurface activationapplication of adhesive agentcovalent binding of low molecular heparin by end-point attachmentinteraction of active heparin sequences with circulating blood
21GORE-TEX® PROPATEN Vascular Graft stability proven in vitro – marginal heparin release within 24 himproved patency rates after 6 months ( Fig. 1)Test animal: dogImplantation site: Arteria carotis shunt modelØ: 3mm, length: no statementno thrombus formation on bioactive surface after implantation for 2 h ( Fig. 2)
22FlowLine 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!
23FlowLine Bipore® Heparin – Coating no effect on the graft handling• implantation technique• anticoagulationno modification of mechanical features of ePTFE graft
24Dynamic Blood Test Using a Chandler Loop Model ePTFE graft Ø: 6 mm, l: 50 cmblood: 18 ml heparin: 1,2 IU/ml contact time: 2hH.P. Wendel Clinical Research Laboratory, Dept. of Thoracic and Cardiovascular Surgery, University of Tübingen
25Dynamic Blood Test Using a Chandler Loop Model Platelets [x103/µl]C: ControlP: ePTFE graftH: FlowLine Bipore®HeparinC P H C P H C P H
26Dynamic Blood Test Using a Chandler Loop Model ePTFE graft after 2 hours of blood contactFlowLine Bipore® Heparin after 2 hours of blood contact
27Comparison of Product Range JOTEC vs GORE-TEX JOTEC Thin Wall, w/o reinforcementGore Thin Wall, w/o reinforcementLength [cm]Ø [mm]Catalogue-No.40515TW4005Nnot available506 7 815TW5006N 15TW5007N 15TW5008N6 not available 88015TW8006N 15TW8007N 15TW8008N
28not available not available not available Comparison of Product Range JOTEC vs GORE-TEXJOTEC Thin Wall, reinforcedGore Thin Wall, reinforcedLength [cm]Ø [mm]Catalogue-No.40515TW4005Snot available506 7 815TW5006S 15TW5007S 15TW5008Snot available not available not available7015TW7005Snot available 68015TW8006S 15TW8007S 15TW8008S6 not available 8
29JOTEC Product Range Thin Wall Standard Wall w/oreinforcement reinforcedw/o reinforcementL [cm]Ø [mm]105206 740-506 7 87080
30Product Advantagescoating of inner surfaceno toxic substancesstable covalent binding of heparinbioactive heparin sequences freely accessiblehigh permanent hemocompatibilitywidest product spectrum