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.

This milestone allows the advancement of a potential treatment for nearly three million US patients living with severe CVI caused by dysfunctional valves in deep leg veins.

These patients currently have limited effective treatment options, and the study will explore a minimally invasive approach.

enVVeno Medical CEO Robert Berman said: “We have been working very closely with the FDA to ensure that the TAVVE study is structured to provide everything that the FDA wants to see in evaluating the safety and efficacy of enVVe and that we are in complete alignment.

“A transcatheter-based non-surgical replacement venous valve has always been considered the ‘holy grail’ for patients with severe CVI, and the interest and enthusiasm among physicians and their clinical teams has been extremely high.

“We are excited to be able to officially start the process of selecting and activating clinical sites and look forward to the first implantation procedure using the enVVe System.”

The TAVVE study is scheduled to begin later this year with an initial cohort of ten patients, whose 30-day safety results will be sent to the FDA for review. This group will continue to be monitored and their progress shared publicly.

The second stage will enrol 220 patients: 165 will receive the enVVe valve, and 55 will be randomised to standard care, across up to 40 clinical sites in the US.

The study includes interventional radiologists, vascular surgeons and interventional cardiologists.

Key features of the enVVe System include a minimally invasive procedure, a self-expanding frame of a biocompatible nickel-titanium alloy, three valve sizes, a mono-cusp leaflet from porcine pericardium, and a compact 13-Fr delivery profile.

In April 2024, enVVeno Medical announced positive top line efficacy data from its SAVVE clinical trial examining its VenoValve, demonstrating that 94% of patients using the valve showed clinical improvement.