enVVeno Medical presents topline efficacy data from SAVVE trial

enVVeno Medical announced the presentation of topline efficacy data showing significant clinical improvement from the SAVVE U.S. pivotal trial for the VenoValve at the 2024 Charing Cross International Symposium in London, UK. The data being presented shows that for patients experiencing a Clinical Meaningful Benefit, the overall average rVCSS improvement was 8.46 points, including 9.29 points for patients at the two-year milestone, 8.08 points for patients at the one-year milestone, and 8.71 points for patients at the six-month milestone. All rVCSS evaluations were based on the patient’s most recent clinical visit, compared to baseline, for a weighted average of eleven months following VenoValve implantation for the Clinical Meaningful Benefit patient cohort. Overall, 94% of the study patients receiving the VenoValve have shown clinical improvement as measured by rVCSS at a weighted-average patient follow-up of 11.04 months for the clinical improvement cohort, and 72% of the study patients have improved the three or more rVCSS points needed to demonstrate the VenoValve’s Clinical Meaningful Benefit, at a weighted-average patient follow-up of 11.64 months for the Clinical Meaningful Benefit cohort. Total patient follow-up was 762 months and 582 months, respectively, for the two patient cohorts.