enVVeno Medical presents two-year follow-up data from VenoValve trial

enVVeno Medical (NVNO) announced that interim two-year follow-up data on 34 subjects from the VenoValve U.S. pivotal trial will be presented today by Dr. Matthew Smeds, Professor of Surgery in the Division of Vascular and Endovascular Surgery at Saint Louis University and Principal Investigator for the trial, at the Vascular and Endovascular Surgery Society 2025 Annual Winter Meeting, being held February 6-9, 2025 in Breckenridge, CO. The Company has submitted a pre-market authorization application for the VenoValve to the U.S. Food and Drug Administration, and the review process is ongoing, with a decision anticipated in the second half of 2025. Key interim two-year follow-up data being presented at VESS includes: 78% of subjects maintained a clinically meaningful benefit, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score. Among the responder cohort, the average rVCSS improvement increased from 6.6 points at 12 months to 8.2 points at 24 months, demonstrating increasing benefit over time. At 24 months, subjects continued to experience a median 75% reduction in pain, as measured by the Visual Analog Scale. Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators from 12 months to 24 months. Among the subjects with core lab-evaluable data at 24 months, a 100% device patency rate was observed in all 27 subjects. The rVCSS is a clinically validated scoring system used to track the progression or regression of venous diseases. The FDA previously indicated that an improvement of 3 or more points in rVCSS would be evidence of the VenoValve’s clinical benefit.