A report from WL Gore & Associates’ medical division has confirmed that a study of the GOREVIABAHN FORTEGRA venous stent for individuals with deep venous iliocaval obstruction met its primary endpoint.
The multicentre, single-arm, international, prospective, non-randomised trial involved 89 subjects diagnosed with deep venous disease.
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It assessed the performance of the device over 12 months in those experiencing symptomatic disease. The trial also includes the inferior vena cava (IVC), as well as the iliac and femoral veins.
The findings were presented by the trial’s co-primary investigator and the UK’s St Thomas’ Hospital surgery chief Stephen Black during the VEINS (Venous Endovascular INterventional Strategies) educational event held in Las Vegas in the US state of Nevada from 1 to 4 November 2025.
All subjects who received the treatment had thrombotic disease: acute, subacute, chronic or post-thrombotic syndrome, with 94.3% presenting with lesions affecting three vessel regions, including the IVC and bilateral iliofemoral veins.
68.5% of subjects needed stents that were placed below the inguinal ligament into the common femoral vein.
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By GlobalDataAfter 12 months, primary patency was achieved in 83.4% of subjects. The findings also indicated a patency rate of 96.5% within the IVC, 88.9% in the left iliofemoral region and 89.8% in the right iliofemoral region.
The study reported no stent embolisations or migrations, vascular injuries, fractures, or clinically significant pulmonary embolisms during 12 months of follow-up, with no mortalities or major bleeding events related to the device recorded within the 30 days.
Black said: “These trial results demonstrate promising outcomes for patients with significant iliocaval disease.
“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.”
The self-expanding nitinol stent is designed for restoring and maintaining patency in both the IVC as well as iliofemoral veins.
It is not currently commercially available and remains under premarket approval review by the US Food and Drug Administration (FDA).
