enVVeno Medical submits VenoValve PMA application to FDA

enVVeno Medical (NVNO) has submitted its application with the U.S. Food and Drug Administration seeking approval to market and sell the VenoValve in the United States. Four out of five modules that comprise the VenoValve PMA application have been submitted, reviewed and approved by the FDA. The fifth and final module of the application contains the clinical data from the SAVVE pivotal trial as well as proposed labeling for the device. The VenoValve, which has been designated as a breakthrough device by the FDA and is therefore subject to priority review, is intended to treat severe deep venous Chronic Venous Insufficiency, a debilitating disease that is most often caused by blood clots in the deep veins of the leg. When valves inside of the veins of the leg fail, blood flows in the wrong direction and pools in the lower leg, causing pressure within the veins of the leg to increase. The Company is also developing a next-generation, non-surgical transcatheter based replacement venous valve called enVVe, which could appeal to an even larger market in terms of both patients and physicians. The Company expects enVVe to be ready for its own pivotal trial during the middle of 2025.