enVVeno Medical today announced it has submitted an application with the U.S. Food and Drug Administration (FDA) seeking approval to market the VenoValve—a surgical venous valve implant for chronic venous insufficiency—in the USA. Definitive one year data from the application are to be presented on Wednesday at the 51st Annual VEITHsymposium in New York City (19–23 November).
“We are thrilled to get this last step of the PMA [pre-market approval] review process underway and look forward to further interactions with the FDA,” said Robert Berman, enVVeno Medical’s CEO. “It is difficult to predict precisely how long the PMA process will take, but we expect to learn more and potentially have a decision in the second half of 2025.”
The VenoValve, which has been designated as a breakthrough device by the FDA and is therefore subject to priority review.
The company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe. It is expected to be ready for its own pivotal trial during the middle of 2025.
