enVVeno’s VenoValve FIH Study Data Published

May 13, 2025—enVVeno Medical Corporation announced the publication of 3-year outcomes from the first-in-human (FIH) study of the company’s VenoValve for the treatment of deep venous reflux.

According to the company, VenoValve is a bioprosthetic replacement venous valve surgically implanted into the femoral vein that is being developed for treatment of severe chronic venous insufficiency (CVI) in the deep veins of the legs.

In the study, the device remained safe and effective at 3-years postimplantation. It achieved a high rate of patency, restored deep venous competence, and maintained clinical benefits, noted the company.

The findings were published by Sebastian Cifuentes, MD, et al online in Annals of Vascular Surgery.

As summarized in enVVeno’s press release, the FIH study was composed of 11 patients with active or healed venous ulcers (CEAP classifications C5-C6) who were treated with surgical implantation of the VenoValve implanted in the femoral vein. Eight patients completed 3 years of follow-up.

Results at 3 years included a primary patency rate of 79% (Kaplan-Meier curve), a seven-point improvement in Venous Clinical Severity Score, and an 84% reduction in pain on the Visual Analog Scale. The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits, stated the company.

enVVeno advised that it has submitted a premarket approval application for the VenoValve to the FDA and anticipates a decision in the second half of 2025.