Venous valve developer enVVeno Medical has announced that it will file a request for supervisory appeal of the “not-approvable” letter from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) received on Aug. 19, 2025, in response to its premarket approval (PMA) application for the VenoValve, a surgical replacement for treating severe deep chronic venous insufficiency (CVI).
“Due to our interaction with the FDA to obtain our Breakthrough Device designation, in which the FDA determined that the VenoValve will meet an unmet clinical need, and our clinical trial negotiations to obtain our investigational device exemption (IDE), as well as during our PMA submission interactions, we have established a productive and collaborative working relationship with the FDA over the past several years. We view this supervisory appeal as an opportunity to extend that relationship,” said Robert Berman, CEO of enVVeno Medical.
“Bringing a true first-in-class device through the PMA regulatory process raises unique challenges, and it is not unusual to have sequential collaborative discussions with the agency to address issues that arise during the review process.”
A decision expected by the end of 2025, the company stated.
