enVVeno Medical has unveiled promising long-term data from their VenoValve U.S. pivotal trial, marking a significant advancement in the treatment of chronic venous insufficiency. The interim two-year follow-up results, presented at the Vascular and Endovascular Surgery Society (VESS) 2025 Annual Winter Meeting, demonstrate sustained clinical benefits and device durability.
Dr. Matthew Smeds, Professor of Surgery in the Division of Vascular and Endovascular Surgery at Saint Louis University and Principal Investigator for the trial, presented the findings from 34 subjects at the prestigious gathering in Breckenridge, Colorado.
Sustained Clinical Improvements
The data reveals that 78% of trial participants maintained a clinically meaningful benefit, defined by the FDA as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS). More impressively, the responder group showed enhanced benefits over time, with average rVCSS improvements increasing from 6.6 points at the one-year mark to 8.2 points at two years post-procedure.
Pain Reduction and Quality of Life
Pain management outcomes remained robust at the two-year follow-up, with subjects experiencing a median 75% reduction in pain as measured by the Visual Analog Scale. The study also documented sustained improvements across all venous-specific quality of life indicators from the 12-month to 24-month assessments.
Device Performance and Safety
Among the 27 subjects with core lab-evaluable data at the two-year mark, the VenoValve demonstrated a perfect 100% patency rate, underlining the device's durability and reliable performance over an extended period.
Regulatory Status
The company has submitted a pre-market authorization application to the U.S. Food and Drug Administration, with a decision expected in the second half of 2025. The strong two-year data could potentially strengthen the device's position in the ongoing review process.
The rVCSS, a clinically validated scoring system used to assess venous disease progression or regression, serves as the primary measure of efficacy in this study. The FDA's predetermined benchmark of a 3-point improvement in rVCSS as evidence of clinical benefit has been substantially exceeded by the trial results.
