Gore® Sees Viabahn® FDA Approval Extended to Include Synthetic AV Access Grafts

W. L. Gore & Associates has seen the FDA extend its indication for the GORE® VIABAHN® Endoprosthesis to include treatment of  stenosis or thrombotic occlusion at the venous anastomosis of synthetic AV access grafts.

Background

Gore recently gained FDA’s approval to market the longer length of its Viabahn endoprosthesis, making it the longest length such device on the US market. Now it’s followed this up with approval to use the device over the venous anastomosis in arteriovenous access grafts following clinical study results that demonstrated statistical superiority in target lesion primary patency as compared to Percutaneous Transluminal Angioplasty (p = 0.008).

Gore’s Viabahn is the lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available and has a long history of iliac and superficial femoral artery use. It is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner and attached to an external nitinol stent structure.

The ePTFE luminal surface of the endoprosthesis incorporates the CARMEDA® BioActive Heparin Surface (CBAS® Heparin Surface) which is a covalently bonded heparin technology intended to provide sustained thromboresistance.

Physician comments

“I have confidence in the GORE VIABAHN Endoprosthesis,” said Thomas Vesely, MD, Interventional Radiologist at the Vascular Access Center in Frontenac Grove, MO. “The device can be precisely deployed and its flexibility allows placement across the elbow and other challenging venous anastomotic locations. I can rapidly and accurately deploy a GORE VIABAHN Device in an emergent situation, and it will provide effective treatment for stenosis at the venous anastomosis of AV access grafts. The IDE approval study showed that the GORE VIABAHN Device provides longer primary patency when compared to repeated angioplasty for these lesions. For these reasons the GORE VIABAHN Endoprosthesis is an indispensable device in my endovascular toolbox.”

Company comments

“We are pleased to expand the GORE VIABAHN Endoprosthesis to hemodialysis access,” said Ray Swinney, Business Unit Leader for the Gore Peripheral Interventional Business Unit. “We are committed to exceeding the expectations of vascular surgeons, interventional radiologists and interventional nephrologists who have been seeking a better solution for their dialysis access patients.”

Source: W L Gore and Associates, Inc.

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