Gore’s Viabahn Fortegra Venous Stent Evaluated in Deep Venous Iliocaval Obstruction

November 7, 2025—Gore & Associates announced trial results evaluating the investigational Viabahn Fortegra venous stent for the treatment of deep venous iliocaval obstruction. The trial met its primary endpoint, which evaluated device performance through 12 months in patients with symptomatic deep venous disease, stated the company.

Coprimary Investigator Stephen Black, MD, presented the clinical trial data at the VEINS conference. Professor Black is Chief of Surgery at St. Thomas’ Hospital in London, United Kingdom.

According to Gore, the international, multicenter, prospective, nonrandomized, single-arm clinical trial of the Viabahn Fortegra venous stent includes 89 patients with deep venous disease.

The trial included the inferior vena cava (IVC), iliac, and femoral veins. All treated patients had thrombotic disease (acute, subacute, or chronic/post thrombotic syndrome); 94.3% had lesions spanning 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 outlined by the company, the results included the following:

• 83.4% of patients achieved 12-month primary patency
• 96.5% primary patency in the IVC
• 88.9% primary patency in the left iliofemoral vessel region
• 89.8% primary patency in the right iliofemoral vessel region
• No stent embolizations/migrations, fractures, vascular injuries, or clinically significant pulmonary embolisms through 12 months
• No device-related deaths or major bleeding through 30 days

“These trial results demonstrate promising outcomes for patients with significant iliocaval disease,” commented Prof. Black in Gore’s press release. “This is an important step forward in establishing additional treatment options for patients with deep venous obstruction, particularly those with complex anatomy or advanced disease.”

Viabahn Fortega is a self-expanding nitinol venous stent not yet approved for commercial use; it is under premarket approval review by the FDA, advised Gore.