FDA Approves BD's Venovo Venous Stent to Treat Iliofemoral Venous Occlusive Disease
March 14, 2019—BD (Becton, Dickinson and Company) announced that the FDA has granted premarket approval for the Venovo venous stent for the treatment of iliofemoral venous occlusive disease. The Venovo venous stent is now commercially available in the United States. The device is also available in Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore, and Taiwan.
According to the company, the flexible nitinol Venovo stent is specifically designed to reopen blocked iliac and femoral veins to maintain adequate blood flow. The device provides a balance of radial strength, compression resistance, and flexibility for the treatment of symptomatic postthrombotic and nonthrombotic iliofemoral lesions. Additionally, the broad stent sizing allows clinicians to treat large diameter veins and long lesion lengths.
Michael Dake, MD, of the University of Arizona, served as the Principal Investigator for the Venovo investigational device exemption trial. In the company's announcement, Dr. Dake commented, "The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease. 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 company advised that 1-year results from the prospective, multicenter, single-arm VERNACULAR trial demonstrated the safety and effectiveness of the Venovo venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction. The study, which was composed of 170 patients, showed a weighted primary patency rate of 88.3%, with a 96.9% patency rate in nonthrombotic lesions and an 81.3% patency rate in postthrombotic lesions at 12 months, exceeding the performance goal of 74%.
The company also reported that patients in the VERNACULAR trial treated with the Venovo venous stent reported a statistically significant reduction in pain symptoms and improvement in the quality of life (assessed by the Chronic Venous Insufficiency Quality of Life Questionnaire–20) at 12 months from baseline. The Venovo device was also deployed successfully to the target lesion and showed adequate coverage in all cases, and there were no fractures seen at 12 months.