Jan. 6, 2026 — W. L. Gore & Associates’ medical business (Gore) has announced the FDA approval of the Gore Viabahn Fortegra venous stent — previously known as the Gore Viafort vascular stent — for treating deep venous disease in the inferior vena cava (IVC), iliac and iliofemoral veins.
The Fortegra venous stent, the newest addition to the Viabahn Device family, is specifically engineered to treat patients with deep venous disease. It consists of an open-structure, self-expanding wire-wound nitinol frame and an expanded polytetrafluoroethylene (ePTFE) polymer lattice, which is designed for conformability, strength and fracture resistance.
This novel technology helps provide an optimal balance and unique combination of allowing the stent to conform to the natural anatomy while providing compression resistance throughout the entire device. Featuring a wide range of sizes, the Fortegra Venous Stent is appropriate for a wide range of patient anatomies.
Study Design and Outcomes
Gore received Breakthrough Device designation from the FDA for the Fortegra venous stent. This program helps expedite the development and FDA review of medical devices that offer more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.
The international clinical trial was the first prospective trial of its kind to include IVC, iliac and iliofemoral veins. The device was demonstrated to be both safe and effective for its indicated use in 89 patients treated with deep venous disease. The study included a patient population with extensive disease burden: all were treated for thrombotic disease (acute, subacute and post-thrombotic syndrome), 94.3% of patients had lesions that span three vessel regions (IVC + bilateral iliofemoral veins) and 68.5% required stents that extended below the inguinal ligament into the common femoral vein.
Despite the study consisting of patients with extensive disease burden, 12-month primary patency was achieved in 83.4% of patients. Further, results demonstrated 96.5%, 88.9% and 89.8% primary patency in the IVC, left iliofemoral and right iliofemoral vessel regions, respectively. There were no stent embolizations/migrations, fractures, vascular injuries or clinically significant pulmonary embolisms through 12 months. There were also no device-related deaths or major bleeding through 30 days.1 Overall, the study met its 12-month composite efficacy and safety primary endpoint.
Additional information is available at goremedical.com
November 24, 2025 
