Gore’s Viabahn Fortegra Venous Stent Wins FDA Approval

January 6, 2026—Gore & Associates announced FDA approval of the Gore Viabahn Fortegra venous stent—previously known as the Gore Viafort vascular stent—for the treatment of deep venous disease in the inferior vena cava (IVC), iliac, and iliofemoral veins.

Kush Desai, MD, serves as National Primary Investigator of the international clinical trial that demonstrated the device’s safety and effectiveness for its indicated use in 89 patients treated with deep venous disease.

“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,” commented Dr. Desai in Gore’s press release. “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.”

According to Gore, the study included a patient population with extensive disease burden. All patients were treated for thrombotic disease (acute, subacute, and postthrombotic syndrome); 94.3% of patients had lesions that spanned three vessel regions (IVC plus bilateral iliofemoral veins); and 68.5% required stents that extended below the inguinal ligament into the common femoral vein.

As summarized in the press release, 12-month primary patency was achieved in 83.4% of patients with 96.5%, 88.9% and 89.8% primary patency in the IVC, left iliofemoral and right iliofemoral vessel regions, respectively. There were no stent embolizations/migrations, fractures, vascular injuries, or clinically significant pulmonary embolisms through 12 months. There were also no device-related deaths or major bleeding through 30 days.

Overall, the study met its 12-month composite efficacy and safety primary endpoint, stated Gore.