A UNIQUE POLYESTER DRUG/DEVICE VASCULAR GRAFT INTERGARD HEPARIN

Transcription

1 A UNIQUE POLYESTER DRUG/DEVICE VASCULAR GRAFT INTERGARD HEPARIN

2 FACTS ON INTERGARD HEPARIN Most frequent causes of vascular graft failure and associated limb loss 1 Graft occlusion due to the development of thrombosis Intimal hyperplasia at the distal anastomotic site Cumulative limb salvage at 5 years Heparin Bonded Dacron (n=16) PTFE (n=13) Properties of Heparin 2,3,4 Highly potent, natural anticoagulant Well known as an antithrombotic agent Shown to inhibit smooth muscle cell proliferation The INTERGARD Heparin Bonding Process High molecular weight heparin is securely bound to the graft fabric, and is then secured between the collagen layers Designed to allow the antithrombotic and antiproliferative properties of biologically active heparin to be available locally at the graft surface TDMAC-heparin complex prevents rapid release of heparin upon exposure to blood flow In-vitro analysis has demonstrated a stable heparin coating on the inner flow surface for up to 4 weeks, with minimal loss at 7 days 5 Number Number of amputations % Primary patency AK Grafts Cumulative limb Salvage (p<.25) Excellent graft healing and tissue incorporation % No suture hole bleeding % % 59% 49% 5% 41% Heparin Bonded Dacron p=.14 PTFE Years Neointima formation on lumenal surface of INTERGARD Knitted graft

3 INTERGARD HEPARIN A UNIQUE POLYESTER DRUG/DEVICE VASCULAR GRAFT INTERGARD Heparin incorporates biologically active heparin on the fabric of INTERGARD grafts. A prospective, randomised clinical trial demonstrated significantly higher patency rates and significantly lower amputation rates than PTFE. 7 INTERGARD HEPARIN ULTRATHIN INTERGARD Heparin UltraThin is a highly innovative vascular graft designed to improve outcomes of peripheral bypass procedures. With a wall thickness of just.35 mm, INTERGARD Heparin UltraThin is one of the thinnest peripheral graft on the market. InterVascular developed this technological advance to produce a thinner, highly compliant vascular graft in response to the need for an improved alternative for peripheral vascular bypass procedures. The unique polyester knitted matrix creates a compliant vessel with exceptional handling and suturing characteristics, and outstanding anastomotic conformation. INTERGARD Heparin UltraThin is an unique polyester drug/device combination which provides an alternative for peripheral bypass procedures when saphenous vein is not available. Exceptional handling and suturing characteristics Excellent host vessel conformability No suture hole bleeding Available with radial support REFERENCES 1. Mohamed MS, Mukherjee M, Kakkar VV. Thrombogenicity of heparin and nonheparin bound arterial prostheses: an in vitro evaluation. J R Coll Surg Edinb 1998 Jun; 43(3): Gott VL, Whitten JD, Dutton F.C. Heparin bonding on colloidal graphite surfaces. Science 1963;142: Esquivel CO, Bjorck CG, Bergentz SE, et al. Reduced thrombogenic characteristics of expanded polytetrafluoroethylene and polyurethane arterial grafts after heparin bonding. Surgery 1984 Jan; 95(1): Inhibition of rat smooth muscle cell adhesion and proliferation by non-anticoagulant heparins. J Cell Physiol 22 Dec; 193(3): Kazi M; Lundmark K; Religa P; Gouda I; Larm O; Ray A; Swedenborg J; Hedin U 5. Swartbol P, Norgren L. Quantitative analysis of heparin retention on heparin bonded knitted Dacron grafts after exposure to shear stress in vitro. Int Angio 1996 Sep; 15(3): Becquemin JP, Riff Y, Kovarsky S, et al. Evaluation of a polyester collagen-coated heparin bonded vascular graft. J Cardiovasc Surg 1997 Feb;38(1): Devine C, McCollum C; North West Femoro-Popliteal Trial Participants. Heparinbonded Dacron or polytetrafluorethylene for femoropopliteal bypass: Five-year results of a prospective randomized multicenter clinical trial. J Vasc Surg. 24 Nov;4(5): Note: The clinical studies cited above are a selection of articles from a large library of published literature related to vascular surgery. Physicians are encouraged to review all of the published literature in this field in order to appreciate the proper context of each article.

4 INTERGARD HEPARIN product information PHYSICAL AND MECHANICAL PROPERTIES* Knitted Ultrathin Coated polyester fabric Cross-linked Type I bovine collagen Cross-linked Type I bovine collagen Construction Knitted, reverse locknit, external velour Knitted, reverse locknit Water permeability 5ml cm -2 min mmhg 5ml cm -2 min mmhg Wall thickness**.49 mm.35 mm Burst strength** 32.7 kg/cm kg/cm 2 45 suture retention** 3.37 kg 1.83 kg * Testing performed per ANSI/AAMI/ISO 7198:1998/21. ** Test results are for customer evaluation only and do not represent a product specification. STRAIGHT 4 cm length: 7 cm length: 12 mm IGK12-4H 14 mm IGK14-4H 16 mm IGK16-4H 18 mm IGK18-4H 2 mm IGK2-4H 22 mm IGK22-4H 24 mm IGK24-4H 6 mm IGK6-7H 7 mm IGK7-7H 8 mm IGK8-7H 1 mm IGK1-7H radially supported STRAIGHT Diameter Proximal / Distal Supported Total Reference 6 mm 35/15 cm 2 cm 7 cm IGK6RS2H 8 mm 35/15 cm 2 cm 7 cm IGK8RS2H 6 mm 25/15 cm 3 cm 7 cm IGK6RS3H 8 mm 25/15 cm 3 cm 7 cm IGK8RS3H BIFURCATED 5 cm length: 12x6 mm IGK126H 14x7 mm IGK147H 16x8 mm IGK168H 18x9 mm IGK189H 2x1 mm IGK21H 22x11 mm IGK2211H ultrathin STRAIGHT 4 cm length: 6 mm IGKUT6-4H 7 mm IGKUT7-4H 8 mm IGKUT8-4H 7 cm length: 6 mm IGKUT6-7H 7 mm IGKUT7-7H 8 mm IGKUT8-7H ULTRATHIN radially supported STRAIGHT Diameter Proximal / Distal Supported Total Reference 6 mm 35/15 cm 2 cm 7 cm IGKUT6RS2H 7 mm 35/15 cm 2 cm 7 cm IGKUT7RS2H 8 mm 35/15 cm 2 cm 7 cm IGKUT8RS2H 6 mm 25/15 cm 3 cm 7 cm IGKUT6RS3H 7 mm 25/15 cm 3 cm 7 cm IGKUT7RS3H 8 mm 25/15 cm 3 cm 7 cm IGKUT8RS3H 6 mm 2/2 cm 45 cm 85 cm IGKUT6RS45H 8 mm 2/2 cm 45 cm 85 cm IGKUT8RS45H

5 INTERGARD HEPARIN A UNIQUE POLYESTER DRUG/DEVICE VASCULAR GRAFT Higher patency rates and significantly lower amputation rates than PTFE 7 Exceptional handling, suturing and host vessel conformation No suture hole bleeding

6 MCV Headquarters MAQUET Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 747 Phone: (+1) or Fax: (+1) or Additional Contact Address Label Here MAQUET Registered Trademark of MAQUET GmbH & Co. KG Reg. QUG: MCV-BR-6125-EN-1 Copyright by MAQUET, Rastatt 2 9/1 We reserve the right to make technical and construction changes. MAQUET GmbH & Co. KG Kehler Straße 31 D Rastatt, Germany Phone: +49 () Fax: +49 () Service-Hotline: +49 () For local contact: Please visit our website GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions and intensive care. MCV4534