Jaguar8 commented on a stock · Nov 19, 2024 21:16

NEWS

enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval

enVVeno Medical has submitted its PMA application to the FDA for the VenoValve, seeking marketing and sales approval in the United States. Four out of five modules have been approved, with the final module containing clinical data from the SAVVE pivotal trial and proposed labeling.

The FDA-designated breakthrough device aims to treat severe deep venous Chronic Venous Insufficiency (CVI), targeting an estimated 2.5 million U.S. candidates annually.

A decision is expected in the second half of 2025.

The company is also developing enVVe, a next-generation transcatheter-based replacement venous valve, with pivotal trials expected mid-2025.

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Jaguar8

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