enVVeno Medical Corporation announced the publication of promising three-year data from its VenoValve first-in-human trial in the peer-reviewed journal, Annals of Vascular Surgery. The manuscript detailed the sustained safety and effectiveness of the VenoValve.
At three-years post implantation, the VenoValve remained safe and effective, achieving a high rate of patency, restoring deep venous competence, and maintaining clinical benefits in eleven subjects with active or healed venous ulcers (CEAP classifications C5-C6). This demonstrates the device's long-term durability and functional restoration.
This peer-reviewed publication provides strong, long-term evidence supporting the VenoValve's potential as a treatment for severe deep venous CVI. The company has submitted its Premarket Approval (PMA) application for the VenoValve to the U.S. Food and Drug Administration (FDA), with a decision anticipated in the second half of 2025.
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