Envveno Medical has today announced that its manuscript titled, ‘Three-year outcomes of surgical implantation of a novel bioprosthetic valve for the treatment of deep venous reflux’, has been published in the in the peer-reviewed journal, Annals of Vascular Surgery.
The VenoValve was surgically implanted in the femoral vein of 11patients with active or healed venous ulcers (CEAP classifications C5–C6). Eight subjects completed three-year follow-up, with key findings including:
- Primary patency: 79% (Kaplan-Meier curve) at three years
- Symptom relief: Seven-point improvement Venous Clinical Severity Score; 84% reduction in pain on the Visual Analog Scale (VAS)
- The VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits
The VenoValve is a potential first-in-class, surgical replacement venous valve for patients with chronic venous insufficiency (CVI). The company estimates that there are approximately 2.5 million potential new patients each year in the USA that could be candidates for the VenoValve.
A press release issued by the company states that it has submitted a pre-market authorisation (PMA) application for the VenoValve to the US Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.
