The company touts Viabahn Fortegra as the first device for the treatment of deep venous disease in the inferior vena cava (IVC), iliac and iliofemoral veins. It marks 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, the company said in a news release.
Viabahn Fortegra already held FDA breakthrough device designation. Its international clinical trial was the first to include IVC, iliac and iliofemoral veins. The device proved both safe and effective for its indicated use in 89 patients treated with deep venous disease.
The milestone comes one day after Gore announced the planned acquisition of Conformal Medical, further expanding its portfolio.
“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,” said Dr. Kush Desai, national primary investigator in the device’s clinical trials. “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.”
