FDA Approves Indication for Gore's Viabahn to Treat In-Stent Restenosis in SFA

September 22, 2014—Gore & Associates announced that the US Food and Drug Administration (FDA) has approved the Gore Viabahn endoprosthesis for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA). The Gore Viabahn addresses in-stent restenosis by relining the failed bare metal stent and adjacent diseased vessel, providing a long-term physical barrier that extends the life of the intervention.

The low-profile, flexible, self-expanding stent graft has received approval for SFA (de novo, restenotic, and in-stent restenotic disease), iliac artery, and arteriovenous access revision. The device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The ePTFE luminal surface of the Gore Viabahn features Carmeda AB’s CBAS heparin surface, intended to provide sustained thromboresistance (Carmeda is a wholly owned subsidiary of Gore & Associates). The device’s 25-cm stent graft, heparin surface, and expanded ePTFE liner provide a long-lasting solution for treatment of failed bare stents, stated Gore.

According to the company, the safety and efficacy of the Gore Viabahn device in this indication was supported by the randomized RELINE clinical study, in which the lesions in both arms of the study averaged more than 17 cm in length. The study found that the device is statistically superior in target lesion primary patency to percutaneous transluminal angioplasty (PTA), which is the most common frontline interventional treatment of in-stent restenosis.

The RELINE clinical study found that patients in the Gore Viabahn device arm of the study were approximately three times less likely than those in the PTA arm to require a target lesion revascularization (TLR) after 1 year. After 12 months, the device showed a primary patency of 74.8%, more than 45% higher than PTA.

In Gore’s press release, Peter A. Soukas, MD, commented, “The treatment of failed bare metal stents has long been a perplexing problem for vascular specialists, in which only a few treatments are FDA-approved and limited compelling clinical data exist. This new indication for the Gore device and the accompanying data from the RELINE trial provide physicians with the means to intervene confidently on a failed bare metal stent, extending the life of the intervention and improving patient outcomes.” Dr. Soukas is assistant professor of medicine at Brown Medical School in Providence, Rhode Island.