enVVeno Medical Completes Enrollment in SAVVE Pivotal Trial of VenoValve

October 6, 2023—enVVeno Medical Corporation announced that it has achieved full enrollment in the 75-patient SAVVE United States pivotal trial. The trial is being conducted to support the company’s submission for FDA premarket approval (PMA) of the VenoValve, which is intended to restore proper directional blood flow for patients with chronic venous insufficiency (CVI) of the deep veins of the leg.

The company announced commencement of enrollment in the SAVVE trial in October 2021. That announcement stated that the prospective, nonblinded, single-arm, multicenter trial was designed to evaluate the safety and efficacy of VenoValve to improve lower leg blood flow, alleviate symptoms, and improve quality of life for patients with CVI caused by dysfunctional valves in the deep veins of the lower leg. The trial was planned to enroll 75 patients at up to 20 centers in the United States.

On July 5, 2023, enVVeno announced that it had 57 patients enrolled in SAVVE and expected to complete full enrollment by the end of 2023. Eighteen patients were enrolled during the last 2 months.

The company advised that with full enrollment occurring earlier than expected, initial topline safety data from SAVVE are now expected in Q4 2023, and initial topline efficacy data are expected in Q2 2024. PMA eligibility to file for FDA approval of VenoValve is expected in Q3 2024.

The company noted that in addition to the VenoValve, it is also developing the enVVe nonsurgical-based replacement venous valve that is delivered via a transcatheter procedure. The Company expects to be ready for the enVVe pivotal trial in Q3 2024.