Omniflow II biosynthetic vascular prosthesis

Transcription

1 Omniflow II biosynthetic vascular prosthesis A unique solution to challenging clinical situations

2 Designed to resemble autologous vein Haemocompatible Smooth, non-thrombogenic flow surface Good long-term patency, even with poor runoff Non-porous No seeping or seroma formation No needle-hole bleeding No tissue ingrowth Biocompatible Rapidly integrated into host tissue Good resistance to infection Rapid haemostasis after puncturing Good compliance Little intimal hyperplasia Can be anastomosed directly to peripheral blood vessels No need for cuffs, patches or jump grafts

3 The Biosynthetic Solution Smooth Non-thrombogenic Non-porous Crosslinked ovine collagen Reinforcing polyester mesh

4 Rapid integration into host tissue No visible difference between graft and host tissue Weeks to months Original graft Rugged exterior facilitates tissue integration Micro-vascularisation of the graft wall contributes to resistance against infections Host tissue Omniflow II explanted after 7 years as fempop bypass graft (Bio Nova International, data on file)

5 Omniflow II Non-porous and biocompatible Highly biocompatible PTFE Porous and bio-inert Omniflow maintains the integrity of its smooth lumen PTFE displays tissue ingrowth into the lumen Omniflow is biocompatible and well integrated in surrounding tissue Thrombus formation PTFE is bio-inert and poorly integrated in surrounding tissue Data from an experimental dog after 13 months (Ketharanathan & Christie Aust NZ J Surg 1981; 51: )

6 Ease of Handling Handles like a saphenous vein Thin and supple Cut, trimmed and shaped with ease Easy to suture Excellent suture retention Minimal suture-hole bleeding with standard sutures Can be anastomosed directly to peripheral vessels No need for cuffs, patches or jump grafts Ideal for AV access Straight or curved configuration Preformed loop prevents kinking Easy to puncture Rapid maturation Rapid haemostasis after puncturing Responds well to revision

7 The Clinical Solution Peripheral revascularisation Good long-term patency Particularly suitable below the knee Even with poor runoff Good resistance to infections Arteriovenous access High primary and secondary patency Good resistance to infections Early puncturing and rapid haemostasis Vascular repair/patching Good patency Resistant to infection Easy suturing

8 Peripheral revascularisation First choice when no saphenous vein available Patency for below-knee bypass significantly better than PTFE Primary patency for below-knee bypass Good long-term patency up to eight years recorded Secondary patency rates for Omniflow II Koch et al. Zentralbl. Chir. 1996; 121: Nakajima et al. Jpn J Vasc Surg 1996; 5: Milne P. Personal communication. Field P. Data on file, Bio Nova International

9 Arteriovenous access First choice when autologous fistula cannot be made Patency not significantly different from AVF Secondary patency of AV access grafts Excellent patency rates in recent study Patency rates for Omniflow II in AV access Enzler et al. Clin Transplant 1996; 10: Palumbo et al. Abstract presented at the Renal week of the American Society of Nephrology, San Diego, CA 14-19/11/2006.

10 Reduced risk of infection First choice for patients susceptible to infection Smooth flow surface prevents bacterial invasion Femoropopliteal bypass Arteriovenous access Graft revascularisation facilitates immune response and antibiotic therapy Clinical data demonstrates superiority to synthetic prostheses Koch G et al. Zentralbl Chir 1996; 121: Enzler et al. Clin Transplant 1996; 10:

11 Biosynthetic solution overcomes issues Autologous fistula or saphenous vein Other autologous vessel(s) Deep veins Arm veins Radial artery Homologous vein Cryopreserved Transplanted Biological prostheses Cadaveric xenografts Human umbilical vein Synthetic prostheses PTFE Dacron Polyurethane Issues Operating time Graft performance Co-morbidity Patient QOL Product cost Availability Immunosuppression Durability Traceability Cost, supply Patency Infections Handling Biosynthetic prosthesis Ovine collagen with integral polyester mesh Combines biological and synthetic properties Good long-term patency Resistance to infection and aneurysm formation Excellent handling properties Available off the shelf More than 25 years of clinical experience

12 For Sustained Performance