Gore receives CE mark for Gore Propaten Vascular Graft for haemodialysis access

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Gore announced that its Gore Propaten Vascular Graft for haemodialysis access has received CE mark. This graft utilises a unique covalent bonding technology to adhere heparin to the graft surface, known as Carmeda BioActive Surface (CBAS). The surface activity has demonstrated long lasting effectiveness in a clinical explant of up to three years after implantation. It allows blood flowing through the graft to resist thrombosis or clotting.

The graft is composed of an expanded polytetrafluoroethylene (ePTFE) material with excellent handling properties and flexibility for ease of use.

“This is forward progress in adding a new bioactive technology to address the graft failure mode of thrombosis. The Gore Propaten Vascular Graft has been successfully demonstrated in the lower extremities, and it is an exciting new option for hemodialysis use,” said Eric Chemla, consultant renal transplant and vascular surgeon, St. George’s Healthcare, UK National Health Service (NHS) Trust.

The Gore Propaten Vascular Graft has been used in lower extremity applications in the USA since 2006 and in Europe for more than ten years with a reported one year primary patency in below-knee bypasses of 80%, compared with 66% for standard ePTFE and 81% for autologous vein bypasses. With more than 18,000 dialysis access implants worldwide, this vascular graft is the only of its kind on the market approved for hemodialysis access.

 

Interim results of a prospective, non-randomised study comparing Gore Propaten Vascular Graft to a non heparin-bonded graft in high–risk patients for hemodialysis access application found that the Gore grafts have a significant improvement of 20% in clot free survival compared to the control group.

The Gore Propaten Vascular Graft is now available in multiple configurations including 4 – 7mm tapers and integrated rings. The Gore Propaten Vascular Graft with integrated rings features the same proprietary end-point covalently as Carmeda BioActive Surface and retains much of the longitudinal extensibility, feel and handling characteristics of a Gore-Tex Stretch Vascular Graft. Furthermore, the cross-sectional profile is reduced by approximately 24% when compared to an externally ringed vascular graft.

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