enVVeno Medical Corporation presented positive interim two-year follow-up data on 42 subjects from the 75-person VenoValve U.S. pivotal trial at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting. The data showed that 83% of subjects maintained a clinically meaningful benefit, defined as a three or more point improvement in Revised Venous Clinical Severity Score (rVCSS), at 24 months.
The average rVCSS improvement among the clinically meaningful benefit cohort was 9.1 points, indicating sustained and significant patient improvement. Subjects also experienced a median 74% improvement in leg pain, demonstrating a tangible impact on patient comfort.
Interim follow-up data indicated sustained improvements across all venous-specific quality-of-life indicators, further reinforcing the VenoValve's comprehensive benefits. A decision from the U.S. Food and Drug Administration (FDA) on the VenoValve is anticipated in the second half of 2025, making this data highly relevant for the ongoing review.
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