EnVVeno Medical announced three-year outcomes for its heart valve that it aims to submit to the FDA this year. The company (formerly Hancock Jaffe) develops the VenoValve system. The potential first-in-class surgical replacement valve could provide a treatment for patients with severe deep venous chronic venous insufficiency (CVI). According to a news release, the company submitted an FDA pre-market authorization (PMA) application for the valve. It expects a decision in the second half of this year.
EnVVeno had its manuscript detailing three-year outcomes for its novel bioprosthetic valve published in the peer-reviewed Annals of Vascular Surgery journal. Findings covered the use of VenoValve heart valve implant in the treatment of deep venous reflux.
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Investigators surgically implanted VenoValve in the femoral vein of eleven subjects with active or healed venous ulcers. Eight subjects completed three years of follow-up.
Key findings included 79% primary patency at three years. For symptom relief, patients reported a seven-point improvement in the Venous Clinical Severity Score. They also saw an 84% reduction in pain on the Visual Analog Scale (VAS).
EnVVeno reported that VenoValve remained safe and effective, achieving target patency and maintaining competence and clinical benefits.
In addition to VenoValve, the company has a separate replacement valve under development for deep venous CVI. Its EnVVe device could offer a non-surgical, transcatheter option. Both act as one-way valves to help assist in propelling blood up the leg and back to the heart and lungs. EnVVeno currently has the final testing underway to seek approval for a pivotal trial of EnVVe.
