W. L. Gore & Associates has received CE Mark approval under MDR for the GORE VIABAHN FORTEGRA Venous Stent, supporting its use in Europe for symptomatic inferior vena cava and iliofemoral venous outflow obstruction.

This is important as deep venous disease can be difficult to manage, especially when obstruction affects complex anatomy such as the inferior vena cava and iliac veins. These patients need devices that can maintain flow while adapting to the movement and compression forces within large veins.

The FORTEGRA Venous Stent is designed with an open-structure, self-expanding nitinol frame and a polymer lattice. This combination aims to balance conformability with compression resistance, allowing the device to adapt to venous anatomy while maintaining support.

The stent was evaluated in a prospective trial that included the inferior vena cava, iliac and iliofemoral veins. Amongst patients who had pain at baseline, 81 percent showed pain improvement at 12 months, while primary patency remained high at 83.4 percent overall. No device-related safety concerns were observed.

The approval follows recent US FDA approval, giving Gore a broader commercial pathway for the device across major vascular markets. The development shows how venous intervention is becoming more specialised. Rather than adapting arterial technologies for venous use, companies are now building devices around the specific mechanical and anatomical challenges of deep venous disease.