enVVeno Medical Corporation presented interim two-year follow-up data from 34 subjects in the VenoValve pivotal trial at the VESS 2025 Annual Winter Meeting. The data showed sustained clinical improvement and continued patient benefit from 12 months to 24 months.
Specifically, 78% of subjects maintained a clinically meaningful benefit, defined as more than a 3-point improvement in revised Venous Clinical Severity Score (rVCSS), at 24 months. The average improvement among the responder cohort was 8.2 points, reinforcing the long-term efficacy of the VenoValve.
This extended follow-up data is crucial for demonstrating the durability and sustained performance of the device, providing strong evidence to support its Premarket Approval (PMA) application with the FDA.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.