enVVeno Medical wins FDA IDE approval for enVVe pivotal trial in deep venous insufficiency
NVNO•FDA clears U.S. pivotal study
enVVeno Medical received FDA IDE clearance for a U.S. pivotal study of its enVVe bioprosthetic venous valve system.
The company said the TAVVE trial is slated to start in Q4 2026 and will target about 230 patients at up to 40 U.S. sites.
