enVVeno Medical has received the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a pivotal study involving a non-surgical replacement venous valve.

The approval enables enVVeno Medical to begin the Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study of the enVVe system, aimed at treating severe deep chronic venous insufficiency (CVI).

Deep venous CVI, commonly due to deep vein thrombosis, leads to blood pooling and increased venous pressure in the legs.