EnVVeno Medical's VenoValve Study Published with Positive Three-Year Results

EnVVeno Medical Corporation announced significant findings from its VenoValve first-in-human trial, now published in the Annals of Vascular Surgery. The study reveals that three years post-implantation, the VenoValve maintains safety and effectiveness. Key outcomes showed a 79% primary patency rate and major relief from symptoms, including a 7-point improvement on the Venous Clinical Severity Score.

The VenoValve targets severe Chronic Venous Insufficiency (CVI) and is designed to significantly benefit approximately 2.5 million potential new U.S. patients annually. EnVVeno has submitted its PMA application to the FDA, with a decision expected by late 2025. This development could redefine treatment approaches to deep venous diseases.