European approval comes about six months after the stent picked up FDA approval.
The company labeled Viabahn Fortegra the first device for the treatment of deep venous disease in the inferior vena cava (IVC), iliac and iliofemoral veins. It’s the latest addition to the Viabahn device family, engineered to treat patients with deep venous disease.
Viabahn Fortegra features an open-structure, self-expanding, wire-wound nitinol frame and an expanded polytetrafluoroethylene (ePTFE) polymer lattice. Gore designed it for comfortability, strength and fracture resistance. The company says its novel technology helps to provide an optimal balance. It allows the stent to conform to the natural anatomy while providing compression resistance throughout the entire device. Featuring a wide range of sizes, the stent can work in a wide range of patient anatomies.