Gore has announced the US Food and Drug Administration (FDA) approval of the Gore Viabahn Fortegra venous stent—previously known as the Gore Viafort vascular stent—the first device for the treatment of 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.
“The Fortegra venous stent represents a significant advancement in the treatment of patients with the most difficult-to-treat venous obstructive pathology, occlusion of the inferior vena cava, iliac veins and inflow femoral veins.
Patients will benefit from a device that is designed specifically for this disease and its unique anatomic and physiologic challenges, including preservation of optimal flow dynamics through iliocaval confluence and side branch preservation,” says Kush Desai and national primary investigator.
Gore received Breakthrough Device designation from the US FDA for the Fortegra venous stent. This programme helps expedite the development and US 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 and bilateral iliofemoral veins) and 68.5% required stents that extended below the inguinal ligament into the common femoral vein.
