One-year follow-up data on 75 subjects from the VenoValve (Envveno Medical) US pivotal trial were presented by principal investigator Cassius Iyad Ochoa Chaar (Yale School of Medicine, New Haven, USA) at the 2025 American Venous Forum (AVF; 16–19 February, Atlanta, USA), a press release reports.
The data show that trial subjects who had the SAVVE procedure experienced statistically significant improvements in quality of life (QoL) metrics related to venous disease at 12 months compared to baseline as demonstrated by the Venous Insufficiency Epidemiological and Economic Study QoL/Symptoms (VEINES-QoL/Sym) scores.
Envveno Medical shares that it has submitted a premarket authorisation (PMA) application for the VenoValve to the US Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.
“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 [chronic venous insufficiency], 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 VEINES-QoL/Sym questionnaire is a validated, disease-specific instrument to measure patient-reported QoL 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 standardised framework for evaluating treatment outcomes and guiding clinical decision-making.
