- BD said it received FDA premarket approval for the first stent indicated to treat iliofemoral venous occlusive disease, in which blood flow to the iliac and femoral veins near the groin is obstructed.
- The Venovo stent, approved by the agency last week, is designed to reopen blocked veins, which pose different challenges than lesions in the arteries.
- One-year results from the Vernacular trial of 170 patients demonstrated the safety and effectiveness of the stent, supporting its approval, BD said.
Franklin Lakes, New Jersey-based BD edged out several contenders for the distinction of being first to market in the United States with a stent to treat venous occlusive disease. Caused by conditions such as deep vein thrombosis, post thrombotic syndrome and iliofemoral vein compression, the disease prevents proper blood circulation and can lead to pain, swelling and ulcers in patients.
The company's Vernacular study showed 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, exceeding the performance goal of 74%. In addition, patients treated with the stent reported a statistically significant reduction in pain symptoms and improvement in quality of life at 12 months.
FDA is requiring a post-approval study to evaluate the long-term effectiveness and safety of the device in the clinical trial patients from the VERNACULAR pivotal study that supported approval.
"The primary endpoint to be assessed is freedom from target lesion revascularization (TLR) at 36 months," FDA wrote in the approval letter. "In addition, the results from any post approval study should be included in the labeling as these data become available."
Several other medtechs are working to bring a peripheral venous stent to the U.S. market. Medtronic's Abre stent for use in the iliofemoral veins received CE mark approval in 2017, and the company has a study under way that it has said it intends to use to support an FDA premarket approval application.
Boston Scientific sells a stent in Europe called Vici, acquired through its August 2018 buyout of privately held Veniti, for the treatment of venous occlusive disease. Veniti in June submitted a premarket approval application for the device to FDA.
Cook Medical sells the Zilver Vena venous stent in Canada and Europe for treating obstructed iliofemoral veins and also is studying its stent in the United States.
BD's Venovo stent allows clinicians to treat large diameter veins and long lesion lengths, the company said. The product is also commercially available in Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan.