Significant Clinical Improvements Reported in enVVeno Medical's VenoValve Pivotal Trial

enVVeno Medical Corporation announced significant clinical improvements in VenoValve efficacy data at the 46th Annual Charing Cross Symposium. The trial exhibited an average rVCSS improvement of 8.46 points within a cohort showing a meaningful clinical benefit. Noteworthy improvements include 9.29 points at the two-year milestone, 8.08 points at the one-year, and 8.71 points at the six-month milestone.

The data also revealed that 72% of the patients achieved a Clinical Meaningful Benefit, with 94% showing overall clinical improvement eleven months post-surgery. With these promising results, enVVeno Medical aims to file for VenoValve FDA approval by the fourth quarter of 2024.

CEO Robert Berman expressed satisfaction with the results, noting exceptional patient improvements not just at six months but extending up to two years post-surgery. The SAVVE trial involved 75 CVI patients across 21 U.S. sites, demonstrating substantial potential for VenoValve in severe deep venous Chronic Venous Insufficiency treatment.