enVVeno Medical Corporation presented definitive one-year data from the VenoValve U.S. pivotal trial at the 51st Annual VEITH Symposium. The data showed that 85% of subjects achieved a clinically meaningful benefit, defined as a three or more point improvement in revised Venous Clinical Severity Score (rVCSS).
The average rVCSS improvement for this responder cohort was 7.91 points, demonstrating significant clinical efficacy. Patients also reported a 75% median reduction in pain and an 87% median ulcer area reduction for those with venous ulcers, highlighting the device's impact on patient symptoms.
The trial also reported an impressive 97% target vein patency rate, indicating the VenoValve's sustained functional performance. This compelling data supports the Premarket Approval (PMA) application submitted to the FDA earlier in the week, reinforcing the device's potential for market approval.
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