Topline Efficacy Data from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024
IRVINE, CA / ACCESSWIRE / February 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that topline efficacy data from the VenoValve U.S. pivotal trial will be presented at the 2024 American Venous Forum (AVF) Annual Meeting being held March 3-6, 2024 in Tampa, Florida. The presentation will be made on Wednesday, March 6, 2024, by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial.
The data to be presented will review the comparative clinical status for subjects enrolled in the Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) U.S. pivotal study for the VenoValve at six (6) months compared to baseline, as measured by the revised Venous Clinical Severity Scores (rVCSS).
The rVCSS is an objective grading system used by vascular specialists throughout the world to report clinical outcomes and responses to treatments for venous diseases such as Chronic Venous Insufficiency (CVI). The score consists of 10 categories graded from 0 to 3 and includes patient reported outcomes and physician assessments. For severe CVI patients, such as the subjects enrolled in the SAVVE study, the U.S. Food and Drug Administration (FDA) has indicated that an improvement in rVCSS of 3 points would be considered evidence of the VenoValve's clinical meaningful benefit.
Composite six (6) month rVCSS data will be presented including the overall percentage of patients enrolled in SAVVE that have shown clinical improvement (improvement in rVCSS), the percentage of SAVVE patients that have shown a clinical meaningful benefit from the VenoValve (rVCSS improvement of 3 or more points), and the average rVCSS improvement for those subjects showing clinical meaningful benefit.
In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the FDA considers whether a medical device provides a clinically meaningful benefit compared to existing technologies. Patients who are enrolled in the SAVVE study all failed at least three months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care for venous ulcer patients).
Severe Chronic Venous Insufficiency is a debilitating disease that most often occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg (venous hypertension). Symptoms of severe CVI include leg swelling, pain, edema, and in the most severe cases, recurrent open sores known as venous ulcers. The disease can severely impact everyday functions such a sleeping, bathing, and walking, and is known to result high rates of depression and anxiety. There are currently no effective treatments for severe CVI of the deep vein system caused by malfunctioning valves and the Company estimates that there are approximately 2.5 new patients each year in the U.S. that could be candidates for the VenoValve.