enVVeno Medical announces interim two-year follow-up data on VenoValve trial

enVVeno Medical (NVNO) announced that interim two-year follow-up data on 42 subjects from the 75 person VenoValve U.S. pivotal trial will be presented at the Society for Vascular Surgery Vascular Annual Meeting being held June 4-7 in New Orleans, Louisiana. Key interim two-year follow-up data being presented at VAM25 include: 83.3% of subjects maintained a clinically meaningful benefit, defined as an improvement of three or more points in the revised Venous Clinical Severity Score; 9.1 point average rVCSS improvement among the responder cohort; a median 74% improvement in leg pain, as measured by the Visual Analog Scale. Wound healing outcomes in 17 subjects with 25 ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size. Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators. Among the subjects, a 100% valve patency rate. All values were calculated comparing each patient’s baseline levels to the reported values at the patient’s 24-month visit. The Revised Venous Clinical Severity Score is a clinically validated scoring system used to track the progression or regression of venous diseases.