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enVVeno Medical to Present Definitive One Year Data from the VenoValve U.S. Pivotal Trial Today at the 51st Annual VEITH Symposium
85% Clinical Meaningful Benefit Responder Rate7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort75% Median Reduction
About this update from Envveno Medical Corporation
[{"type":"text","content":"85% Clinical Meaningful Benefit Responder Rate7.91 Point Average rVCSS Improvement for the Clinically Meaningful Benefit Responder Cohort75% Median Reduction in Pain (VAS)87% Median Ulcer Area Reduction97% Target Vein Patency RateImprovement in All Patient Reported Quality-of-Life IndicatorsCompany to Host Video Conference Call with VEITH Presenters Today at 2:00 PM Eastern Time - Click Here to Access IRVINE, CA / ACCESSWIRE / November 20, 2024 / enVVeno Medical Corporation (NASDAQ:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, will present one year data on all subjects from the VenoValve U.S. pivotal trial today at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City. The definitive one-year data supports the application submitted earlier this week by enVVeno Medical seeking pre-market authorization (PMA) from the U.S. Food and Drug Administration (FDA) to market and sell the VenoValve in the U.S.Among the data being presented at VEITH are:Eighty five percent (85%) of the subjects in the VenoValve pivotal study that reached the one-year milestone achieved a clinically meaningful benefit of a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS).7.91 point average rVCSS improvement among the rVCSS responder cohort.Clinical meaningful benefit was shown across all CEAP diagnostic classes of subjects (C4(b), C4(c), C5, C6) enrolled in the study.Ninety seven percent (97%) Target Vein Patency rate at one year.Hemodynamic data from the study showed a positive correlation between rVCSS improvement and systemic reflux time improvement.rVCSS is a clinically validated scoring system used to track the regression or progression of venous diseases. The FDA previously indicated to the Company that a 3 or more-point improvement in rVCSS would be evidence of the VenoValve's clinical meaningful benefit.Subjects in the VenoValve pivotal study also experienced a median reduction in pain of seventy-five percent (75%) at one year as measured by Visual Analog Scale (VAS). Additionally, among subjects with venous ulcers (CEAP C6), the median ulcer area was reduced by eighty seven percent (87%) at 12 months. Patient reported outcomes in the VenoValve pivotal study also demonstrated improvements in qualit...