FDA grants indication for GORE VIABAHN Endoprosthesis to treat thrombotic occlusion

W. L. Gore & Associates (Gore) today announced that the Food and Drug Administration (FDA) has granted indication for the GORE® VIABAHN® Endoprosthesis to treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access (AV access) grafts.

"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."

In the REVISE Clinical Study (AVR 06-01), the GORE VIABAHN Device group demonstrated statistical superiority of target lesion primary patency as compared to PTA (p = 0.008).

With a long history of iliac and superficial femoral artery use, the GORE VIABAHN Device is the lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available. 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 GORE VIABAHN Endoprosthesis incorporates the CARMEDA® BioActive Heparin Surface (CBAS® Heparin Surface). This proprietary end-point covalently bonded heparin technology is anchored to the graft surface and is intended to provide sustained thromboresistance.

"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."