W.L. Gore & Assoc. said it won pre-market approval from the FDA for its 25cm Viabahn endoprosthesis for peripheral arterial disease, claiming the device as the longest stent graft available in the U.S.
Newark, Del.-based Gore said the FDA approved the Viabahn device, which is treated with a heparin bio-active coating, for treating symptomatic PAD in the superficial femoral artery.