EnVVeno Medical released promising three-year data for its VenoValve system, a first-in-class surgical heart valve for severe deep venous chronic venous insufficiency (CVI). The company has submitted a pre-market approval (PMA) application to the FDA and anticipates a decision in the second half of 2025.
Key results from 11 patients (8 with full follow-up):
- 79% primary patency at 3 years
- 7-point improvement in Venous Clinical Severity Score
- 84% pain reduction on the Visual Analog Scale (VAS)
VenoValve showed sustained safety, efficacy, and symptom relief in patients with active or healed venous ulcers.
EnVVeno is also developing EnVVe, a non-surgical, transcatheter valve for CVI, and is preparing for a pivotal trial.
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