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     129  0 Kommentare New Interim Venous Ulcer Healing Data from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024

    IRVINE, CA / ACCESSWIRE / June 17, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that new interim venous ulcer healing data …

    IRVINE, CA / ACCESSWIRE / June 17, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today 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 (SAVVE) 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 (FDA) 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 (3) months of conventional treatment with existing technologies (compression therapy, leg elevation, and wound care) 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.

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    New Interim Venous Ulcer Healing Data from the enVVeno Medical VenoValve(R) Pivotal Trial to be Presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting on June 21, 2024 IRVINE, CA / ACCESSWIRE / June 17, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that new interim venous ulcer healing data …