W. L. Gore & Associates Medical Products has received CE Mark approval under the Medical Device Regulation (MDR) for the GORE® VIABAHN® FORTEGRA Venous Stent.
The device is indicated for treating symptomatic inferior vena cava and iliofemoral venous outflow obstruction. The approval follows its recent clearance by the U.S. FDA and expands access to the treatment option across European markets.
The FORTEGRA Venous Stent is the newest addition to the VIABAHN® portfolio, specifically designed to treat patients with deep venous disease. It features a self-expanding wire-wound nitinol frame combined with a polymer lattice, providing flexibility, strength and resistance to fracture.
The design enables the stent to adapt to the body's natural anatomy while maintaining compression resistance, making it suitable for a wide range of patient anatomies.
Clinical evaluation through a prospective trial involving the IVC, iliac and iliofemoral veins demonstrated the device to be safe and effective. At 12 months, 81% of patients with pain at baseline reported improvement, while primary patency reached 83.4%.
The study also showed significant improvements in quality of life, clinical severity, oedema and ulcer-related outcomes, with no device-related safety concerns.
The findings support the stent's role in treating complex venous disease across acute, subacute and post-thrombotic conditions.
