IRVINE, Calif. – enVVeno Medical Corporation (NASDAQ:NVNO), a medical device company, reported positive efficacy data from its pivotal U.S. SAVVE trial for VenoValve, a device designed to treat severe chronic venous insufficiency (CVI). The study results, presented at the annual meeting of the American Venous Forum, showed that 97% of patients experienced clinical improvement as measured by the Revised Venous Clinical Severity Score (rVCSS).
The study demonstrated that 74% of patients experienced clinically significant benefit, defined as an improvement of 3 or more rVCSS points. The average improvement per patient was 8 points, significantly exceeding the threshold set by the US Food and Drug Administration (FDA) to demonstrate clinical significance.
The data, which compared six-month follow-up results with baseline measurements, suggests that VenoValve may provide significant relief to people with CVI who have not responded to traditional treatment.
CVI is often caused by blood clots in the deep veins of the legs, leading to symptoms such as swelling, pain, and in severe cases, venous ulcers. The disease can seriously impact quality of life, and there are currently limited effective treatments for CVI caused by valvular insufficiency. enVVeno estimates that approximately 2.5 million new patients in the United States each year may be candidates for VenoValve.
The company plans to submit an application for FDA approval in the fourth quarter of 2024 following the collection of a full year of data on all SAVVE patients, which will be completed in September 2024. As of December 31, 2023, enVVeno had sufficient capital to fund operations through the pending FDA decision on VenoValve through the end of 2025.
The SAVVE study was a prospective, single-blind, independent study that enrolled 75 patients with cardiovascular disease at 21 US study sites. Dr. Cassius Iyad Ochoa Chaar, principal investigator at Yale School of Medicine, presented the results. A webcast discussing the results was hosted by enVVeno with the participation of Dr. Chaar, highlighting the significant improvement in the patients’ condition.
VenoValve is a first-in-class surgical venous replacement valve developed by enVVeno for the treatment of deep vein CVI. The company is also working on a non-surgical transcatheter venous replacement valve called enVVe for the treatment of deep vein CVI.
This article is based on a press statement from enVVeno Medical Corporation.
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