enVVeno Announces One Year Data from VenoValve U.S. Pivotal Trial

enVVeno Medical Corporation, a company setting new standards of care to treat venous disease, announced that one-year follow-up data from the VenoValve U.S. pivotal trial will be presented at the 37th Annual Meeting of the American Venous Forum. Dr. Cassius Iyad Ochoa Chaar, Associate Professor of Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery, Principal Investigator, and lead enroller for the trial, will present the data.

“We continue to be asked to present our data at leading vascular conferences throughout the world as news of the potential for the VenoValve spreads among vascular surgeons whose practices include the treatment of venous diseases,” said Robert Berman, enVVeno Medical’s Chief Executive Officer. “The VenoValve has the potential to be the first FDA approved treatment for deep venous CVI, and we are attempting to reach the top of a mountain that nobody has successfully climbed and with many failed attempts over the past several decades. With the summit of the mountain finally in sight, this is an exciting time for our company and for the millions of patients with severe deep venous CVI who have no effective treatment options.” 

The Venous Insufficiency Epidemiological and Economic Study Quality of Life/Symptoms (VEINES-QoL/Sym) questionnaire is a validated, disease-specific instrument to measure patient-reported quality of life and symptom severity in individuals with chronic venous disease. By assessing factors such as pain, functional limitations, and psychosocial impacts, VEINES-QoL/Sym provides a standardized framework for evaluating treatment outcomes and guiding clinical decision-making.

The data show that trial subjects who had the SAVVE procedure experienced statistically significant improvements in QoL metrics related to venous disease at 12 months compared to baseline, as demonstrated by the VEINS QoL/Sym scores.

The company has submitted a pre-market authorization (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.