enVVeno Medical to present interim data from VenoValve trial

enVVeno Medical announced that new interim venous ulcer healing data from the VenoValve U.S. pivotal trial will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting (VAM2024) being held June 18-22, 2024 in Chicago, IL. The presentation, entitled “The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux,” will be made on Friday, June 21, 2024 by primary investigator Dr. Cassius Iyad Ochoa Chaar MD, MS, RPVI, Associate Professor of Surgery, Division of Vascular Surgery, Yale School of Medicine, the top enrolling site for the trial.The data to be presented will include venous ulcer healing and improvement rates for venous ulcer patients who have now reached the one-year milestone in the Company’s Surgical Anti-reflux Venous Valve Endoprosthesis (U.S. pivotal study for the VenoValve. Overall healing or improvement rate data for thirty-one ulcers among twenty-one patients will be presented, and the presentation will also include sub-categories for ulcers that existed for more than one year and less than one year prior to the VenoValve surgery. Recurrence rate data for any venous ulcers that fully healed, and then recurred, will also be presented. Excerpts from the presentation will be made available on the Company’s website. In assessing the benefit and risk of a novel technology such as the VenoValve, which addresses an unmet medical need, the U.S. Food and Drug Administration considers whether a medical device provides a clinically meaningful benefit compared to existing technologies. Subjects with venous ulcers who were enrolled in the SAVVE study all received at least three months of conventional treatment with existing technologies and many also received vein ablations for superficial venous disease, and venous stenting for obstruction, if indicated. As a result, the venous ulcer patients in the SAVVE study are the most difficult to treat, having venous ulcers that remained after at least three and as many as five types of existing treatments. The FDA has asked the Company to collect one year data on all SAVVE patients to support its PMA application seeking FDA approval to market and sell the VenoValve, which the Company expects to file in Q4 of this year.