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JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net FlowLine Bipore ® Heparin.

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Presentation on theme: "JOTEC GmbH, Lotzenäcker 23, 72379 Hechingen, Germany, www.jotec.net FlowLine Bipore ® Heparin."— Presentation transcript:

1 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin

2 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  medical device class III  FlowLine Bipore vascular graft  heparin coating of inner surface  wall thickness: 0,4 mm (thin wall) 0,7 mm (standard wall) length: mm diameter: mm  helical PTFE-monofilament reinforcement Product Description

3 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  guideline: JOTEC FlowLine Bipore Heparin Xmm TW  coating not visible  shelf life: 2 years  no resterilization  nomenclature: i.e. 15TW6006S length diameter S: fully reinforced N: no reinforcement FlowLine Bipore Heparin Product Description

4 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  additional label FlowLine Bipore Heparin Heparin covalent bonded Product Description

5 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin Same indications as FlowLine Bipore ®  primarily in the periperal vascular region -femoralpopliteal -axillofemoral -iliacoiliacal -tibial and peroneal arteria  arteriovenous shunt prothesis in hemodialysis Indications

6 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  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 Contraindications

7 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  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 patientsThrombocytopenia (< / µl) Thrombocytopenia (< / 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 Thrombocytopenia

8 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin 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! Thrombocytopenia

9 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  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 Heparin in General

10 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  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 Functional Principle

11 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin NameProducerMarket entryBondingApplication Carmeda BioActive Surface ® Medtronic1985covalent ECC, ventricular assist devices, central venous catheter, coronary stent, ePTFE vascular graft (Gore) Duraflo II ® Baxter1988ionic ECC Bioline Coating ® Jostra AG1992covalent with ionic interaction ECC, centrifugal pump, catheter, canules, tubes Established Heparin Coatings

12 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin  InterVascular InterGard™ Heparin  W.L. Gore & Associates GORE-TEX ® PROPATEN Vascular Graft  JOTEC FlowLine Bipore ® Heparin Heparin Coating of Vascular Grafts

13 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin Product nameMaterialHeparinBondingRegistration InterGard TM Heparin Polyester Collagen porcine / high molecular ionic1991 GORE-TEX ® Propaten ePTFE porcine / low molecular covalent2002 FlowLine Bipore ® Heparin ePTFE porcine / high molecular covalent with ionic interaction 2003 Product Comparison

14 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin InterGard™ Heparin PolyesterCollagenHeparin + Adhesive agent GORE-TEX ® PROPATEN ePTFE Heparin Adhesive agent Activated surface FlowLine Bipore ® Heparin Heparin Adhesive agent ePTFE Structural Comparison

15 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin ePTFE Adhesive agent Heparin Covalent bonding + – FlowLine Bipore ® Heparin – Coating

16 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, 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

17 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin InterGard™ Heparin Just a fractional amount of heparin in contact with blood after implantation!

18 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, 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

19 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin InterGard™ Heparin – Randomized Clinical Trial Product brochure InterGard Heparin P/N: 7366/2

20 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, 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

21 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, 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)

22 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, 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!

23 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin FlowLine Bipore ® Heparin – Coating  no effect on the graft handling implantation technique anticoagulation  no modification of mechanical features of ePTFE graft

24 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin H.P. Wendel Clinical Research Laboratory, Dept. of Thoracic and Cardiovascular Surgery, University of Tübingen Dynamic Blood Test Using a Chandler Loop Model 37 °C ePTFE graft Ø: 6 mm, l: 50 cm blood: 18 ml heparin: 1,2 IU/ml contact time: 2h 37 °C

25 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin Platelets [x10 3 /µl] CPHCPHCPHCPHCPHCPH C: Control P: ePTFE graft H: FlowLine Bipore ® Heparin Dynamic Blood Test Using a Chandler Loop Model

26 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin 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 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin 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 TW4005Nnot available TW5006N 15TW5007N 15TW5008N 6 not available TW8006N 15TW8007N 15TW8008N 6 not available 8

28 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin Comparison of Product Range JOTEC vs GORE-TEX JOTEC Thin Wall, reinforcedGore Thin Wall, reinforced Length [cm]Ø [mm]Catalogue-No TW4005Snot available TW5006S 15TW5007S 15TW5008S not available not available not available 70515TW7005S not available TW8006S 15TW8007S 15TW8008S 6 not available 8

29 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin Thin WallStandard Wall w/oreinforcementreinforcedw/o reinforcementreinforced L [cm]Ø [mm]L [cm]Ø [mm]L [cm]Ø [mm]L [cm]Ø [mm] JOTEC Product Range

30 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, 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

31 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin GORE-TEX ® PROPATEN Vascular Graft Product brochure GORE-TEX PROPATEN June 2002 Fig. 1

32 JOTEC GmbH, Lotzenäcker 23, Hechingen, Germany, FlowLine Bipore ® Heparin GORE-TEX ® PROPATEN Vascular Graft Product brochure GORE-TEX PROPATEN June 2002 Fig. 2


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