enVVeno’s VenoValve SAVVE Trial Topline Efficacy Data Presented

April 24, 2024—enVVeno Medical Corporation announced the presentation of topline efficacy data from SAVVE, the United States pivotal trial for the company’s VenoValve.

enVVeno stated that SAVVE is being conducted to support the company’s submission for FDA premarket approval (PMA) of the VenoValve device, which is intended to restore proper directional blood flow for patients with chronic venous insufficiency (CVI) of the deep veins of the leg.

The prospective, nonblinded, single-arm, multicenter study enrolled 75 patients with CVI at 21 sites in the United States. All patients enrolled in the SAVVE trial had shown little or no improvement after at least 3 months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care for venous ulcer patients).

The trial findings were presented by primary investigator David Dexter, MD, at the 2024 Charing Cross International Symposium held April 23-25 in London, United Kingdom. Dr. Dexter is from Sentara Hospital and is Associate Professor of Surgery, at Eastern Virginia Medical School in Norfolk, Virginia.

According to the company, the data show that for patients experiencing a “Clinical Meaningful Benefit”—defined as a revised Venous Clinical Severity Score (rVCSS) improvement ≥ 3 points—the overall average improvement was 8.46 points.

The rVCSS was 9.29 points for patients at the 2-year milestone, 8.08 points for patients at 1 year, and 8.71 points for patients at 6 months. All rVCSS evaluations were based on the patient’s most recent clinical visit, compared to baseline, for a weighted average of 11 months following VenoValve implantation for the Clinical Meaningful Benefit patient cohort.

enVVeno reported that overall, 94% of the study patients who received the VenoValve showed clinical improvement as measured by rVCSS at a weighted-average patient follow-up of 11.04 months for the clinical improvement cohort.

Additionally, 72% of the study patients have shown the ≥ 3-point improvement in rVCSS needed to demonstrate the VenoValve’s Clinical Meaningful Benefit, at a weighted-average patient follow-up of 11.64 months for the Clinical Meaningful Benefit cohort. Total patient follow-up was 762 months and 582 months, respectively, for the two patient cohorts.

VenoValve’s CXS slides will be available on the company’s website after the presentation, noted the enVVeno press release.

In October 2023, the company announced the completion of trial enrollment. Preliminary safety data were presented at the VEITHsymposium in November 2023.

The company advised that it was asked by the FDA to collect a minimum of 1 year of data on all patients enrolled in SAVVE before filing its PMA application. enVVeno stated it expects to have completed this by September 2024.