Becton Dickinson & Co. (NYSE:BDX) said today that the FDA granted pre-market approval for its Venovo stent for treating iliofemoral venous occlusive disease.
Franklin Lakes, N.J.-based BD touted Venovo as the first on the U.S. market approved to treat obstructed blood flow in the iliac and femoral veins.
“The FDA pre-market approval of the Venovo venous stent represents a significant advance for interventionalists treating iliofemoral venous occlusive disease, an under-recognized condition,” peripheral intervention president Steve Williamson said in prepared remarks. “We designed the Venovo venous stent in collaboration with clinicians to enable them to treat both post-thrombotic and non-thrombotic lesions. Clinicians will now have access to the broadest range of stent sizes in the U.S. for these difficult-to-treat lesions.”
“The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease,” added Dr. Michael Dake of the University of Arizona, who was principal investigator for the Vernacular investigational device exemption 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.”
BD said one-year results from the 170-patient Vernacular study showed a weighted primary patency rate of 88.3%, a 96.9% patency rate in non-thrombotic lesions and an 81.3% patency rate in post-thrombotic lesions; the performance goal was 74%. Venovo-treated patients reported a statistically significant reduction in pain symptoms and improvement in quality of life, the company said. The stent was deployed successfully to the target lesion and showed adequate coverage in all cases and there were no fractures as of the 12-month mark.
Venovo is on the market in the U.S., Europe, Argentina, Australia, Brazil, Egypt, India, Israel, Mexico, Russia, Saudi Arabia, Singapore and Taiwan, BD said.