Gore Viabahn Endoprosthesis Approved for Arteriovenous Access Revision

December 11, 2013—Gore & Associates (Flagstaff, AZ) announced that the US Food and Drug Administration has granted an indication for the Gore Viabahn endoprosthesis to treat stenosed or thrombotic occlusions at the venous anastomosis of synthetic arteriovenous access grafts. The device has had approval for use in iliac and superficial femoral arteries.

The company noted that patients treated with the Gore Viabahn device demonstrated statistical superiority in terms of target lesion primary patency as compared to treatment with percutaneous transluminal angioplasty (P = .008) in the REVISE clinical study.

In the company’s press release, Thomas Vesely, MD, who is an interventional radiologist at the Vascular Access Center in Frontenac Grove, Missouri, commented, “I have confidence in the Gore Viabahn endoprosthesis. 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 arteriovenous access grafts. The investigational device exemption 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.”

According to the company, the Gore Viabahn is a low-profile, flexible, self-expanding, small-diameter endoprosthesis that 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 Gore Viabahn endoprosthesis incorporates the company’s Carmeda bioactive heparin surface (CBAS). This endpoint covalently bonded CBAS heparin technology is anchored to the graft surface and is intended to provide sustained thromboresistance, the company stated.