enVVeno’s VenoValve for CVI Evaluated in Pivotal Study 2-Year Interim Data

June 11, 2025—enVVeno Medical Corporation recently announced interim 2-year follow-up data on 42 of 75 patients in the VenoValve United States pivotal trial. VenoValve is a surgical replacement venous valve being developed for the treatment of deep venous chronic venous insufficiency, noted the company.

Cassius Iyad Ochoa Chaar, MD, lead enroller in the trial, presented the findings at the Society for Vascular Surgery’s 2025 Vascular Annual Meeting. Dr. Chaar is Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy, Yale School of Medicine, in New Haven, Connecticut.

According to the company, all values in the findings were calculated comparing each patient’s baseline levels to the reported values at the patient’s 24-month visit. Key interim 2-year follow-up data included the following:

• 83.3% of patients (35 of 42 patients) maintained a clinically meaningful benefit, defined as an improvement of three or more points in the revised Venous Clinical Severity Score (rVCSS).
• A 9.1-point average rVCSS improvement was seen among the responder cohort.
• A median 74% improvement in leg pain, as measured by the Visual Analog Scale, was observed.
• Wound healing outcomes in 17 patients with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size.
• Patient-reported outcomes demonstrated sustained improvements across all venous-specific quality-of-life indicators in the VEINES-QoL/Sym questionnaire.
• A 100% valve patency rate was achieved in 30 patients.

In November 2024, enVVeno announced that 1-year data on all patients from the pivotal trial were presented at the VEITHsymposium and that it submitted a premarket approval application to the FDA to commercialize the VenoValve in the United States.

A decision from the FDA is anticipated in the second half of 2025, advised the company.