enVVeno Medical to present topline efficacy data from VenoValve trial

enVVeno Medical announced that additional topline efficacy data from the VenoValve U.S. pivotal trial will be presented at the 2024 Charing Cross International Symposium being held April 23rd – 25th in London, England. The presentation, entitled “Efficacy Results of the SAVVE Trial: Long-term Results for Use of a Bioprosthetic Valve for Patients with Chronic Deep Venous Reflux,” will be made on Wednesday, April 24, 2024 by primary investigator Dr. David Dexter, Sentara Hospital, Norfolk, Virginia and Associate Professor of Surgery, Eastern Virginia Medical School. The data to be presented will review the comparative clinical status for subjects enrolled in the Surgical Anti-reflux Venous Valve Endoprosthesis U.S. pivotal study for the VenoValve at a composite weighted average of eleven months post VenoValve implantation, comparing the clinical results from subjects’ most recent clinical visit to baseline, as measured by the revised Venous Clinical Severity Score. The composite eleven month weighted average rVCSS data will include nine subjects that have passed the twenty-four month milestone, thirty-one subjects that have passed the twelve month milestone, and twenty-nine subjects that have passed the six month milestone, representing an aggregate of 64 patient-years of follow-up. The rVCSS is an objective grading system used by vascular specialists throughout the world to report clinical outcomes and responses to treatments for venous diseases such as Chronic Venous Insufficiency. The score consists of 10 categories graded from 0 to 3 and includes patient reported outcomes and physician assessments. For severe CVI patients, such as subjects enrolled in the SAVVE study, an improvement in rVCSS of 3 or more points would be considered evidence of the VenoValve’s Clinical Meaningful Benefit. Weighted average composite eleven month rVCSS data will be presented during the presentation including the average rVCSS improvement for those subjects showing greater than or equal to 3 point rVCSS improvement, sub-analyses of the Clinically Meaningful Benefit cohort by most recent clinical visit grouping and CEAP classification, as well as the overall percentage of SAVVE subjects that have shown a Clinical Meaningful Benefit, and the overall percentage of subjects enrolled in SAVVE that have shown clinical improvement. In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the FDA considers whether a medical device provides a clinically meaningful benefit compared to existing technologies. Subjects who were enrolled in the SAVVE study all failed at least three months of conventional treatment with existing technologies