FDA Approves Venovo Stent for Iliofemoral Venous Occlusive Disease

The US Food and Drug Administration (FDA) has granted premarket approval to Becton, Dickinson, and Company (BD) for the Venovo venous stent. The stent is the first indicated to treat iliofemoral venous occlusive disease—obstructed or narrowed blood flow in the iliac and femoral veins, which are located near the groin.

Iliofemoral venous occlusive disease is caused by impaired blood flow in the iliofemoral vein that may be caused by acute or chronic deep-vein thrombosis, post-thrombotic syndrome, iliofemoral vein compression including May-Thurner Syndrome, or a combination of those conditions.

The device is a flexible stent made of nitinol that balances the needs for flexibility, radial strength, and compression resistance. The stent comes in many sizes in both diameter and length.

"The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease," said Michael Dake, MD, University of Arizona and the principal investigator for the VERNACULAR trial. "Most importantly, it is purpose-built for application in veins, and engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing."

The FDA’s decision to approve was supported by 1-year data from the prospective, single-arm VERNACULAR trial that assessed the safety and efficacy of the Venovo venous stent. The study included 170 participants who were treated with the Venovo stent for symptomatic iliofemoral venous outflow obstruction.

The study found a weighted primary patency rate of 88.3%, with a 96.9% patency rate in non-thrombotic lesions, and an 81.3% patency rate in post-thrombotic lesions at 12 months. This exceeded the performance goal of 74%. Additionally, the Venovo stent showed adequate coverage of the target lesion in all cases, and no fractures were seen at 12 months.

"The FDA premarket approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an underrecognized condition," said Steve Williamson, worldwide president of Peripheral Intervention at BD.

Williamson highlighted that the stent was developed in collaboration with clinicians and designed to treat both post-thrombotic and non-thrombotic lesions. “Clinicians will now have access to the broadest range of stent sizes in the US for these difficult-to-treat lesions," he added.

The Venovo venous stent is now available in the US, Europe, and several countries in South America, the Middle East, and Asia.