FDA approves BD’s Venovo stent
Posted on March 14, 2019 by Medtech[y] Staff
Earlier this week, BD (Becton, Dickinson and Company) announced the FDA premarket approval for the Venovo venous stent, which is the first stent indicated to treat iliofemoral venous occlusive disease.
Patients with Iliofemoral venous occlusive disease have impaired blood flow in the iliofemoral vein, which is caused by acute or chronic deep-vein thrombosis, iliofemoral vein compression including May-Thurner Syndrome, post-thrombotic syndrome, or a combination of these diseases.
"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. "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 Venovo venous stent received pre-market approval after one-year results from the prospective, multicenter single-arm VERNACULAR trial demonstrated the safety and effectiveness for the treatment of symptomatic iliofemoral venous outflow obstruction.
The VERNACULAR study included 170 patients and the clinical findings showed a weighted primary patency rate of 88.3 percent, with a 96.9 percent patency rate in non-thrombotic lesions and an 81.3 percent patency rate in post-thrombotic lesions at 12 months, which exceeded the performance goal of 74 percent.
Additionally, the patients treated with Venovo reported a statistically significant quality of life improvement and reduction in pain symptoms at 12 months from baseline.
"The unique attributes of the Venovo stent make it particularly well-suited to treat iliofemoral occlusive disease," said Dr.Michael Dake, University of Arizona and the principal investigator for the Venovo IDE 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."