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enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve(R)
IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received a not-approvable ...
About this update from Envveno Medical Corporation
[{"type":"text","content":"IRVINE, CA / ACCESS Newswire / August 20, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received a not-approvable letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve®, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI).","length":503,"tagName":"p"},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":278,"height":85,"url":"https://media.zenfs.com/en/accesswire.ca/f5f0a41806fe3ea0080503838042538f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/FKUPmHCoxPXKsbE_86gCsw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEyODtjZj13ZWJw/https://media.zenfs.com/en/accesswire.ca/f5f0a41806fe3ea0080503838042538f","width":278,"height":85}}},{"type":"text","content":"The letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form. In particular, the FDA indicated that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve. Without a specific hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias and the possibility that clinical improvement occurred as a result of the patients being enrolled in a study.","length":761,"tagName":"p"},{"type":"text","content":"The FDA also focused on safety concerns which were attributed to the VenoValve open surgical procedure, and that required re-hospitalizations. The Company would not expect to see similar safety events with a non-surgical replacement valve.","length":239,"tagName":"p"},{"type":"text","content":""We are obviously disappointed by the FDA's decision. The results showed that a high percentage of the patients in the SAVVE study, who all previously failed standard of care treatments, showed significant c...