W.L. Gore & Associates has received FDA approval for the Gore Viabahn Fortegra Venous Stent — the first device indicated to treat deep venous disease in the inferior vena cava, as well as the iliac and iliofemoral veins.
Formerly known as the Gore Viafort Vascular Stent, the device is designed for conformability and resistance to compression, according to a Jan. 6 news release. It features an open-structure, self-expanding nitinol frame with a polymer lattice and is available in a wide range of sizes to fit varying patient anatomies.
In a clinical trial of 89 patients with extensive thrombotic disease, the stent achieved 12-month primary patency in 83.4% of cases. Regional patency rates reached 96.5% in the IVC, 88.9% in the left iliofemoral vein and 89.8% in the right iliofemoral vein. No device-related deaths, stent fractures or clinically significant pulmonary embolisms were reported.
The device received breakthrough device designation from the FDA and met its 12-month safety and efficacy endpoints.
