enVVeno Receives Not-Approvable Letter From the FDA for the VenoValve(R)

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…

FDA Issues Not-Approvable Letter for enVVeno’s VenoValve for CVI - Endovascular Today

August 20, 2025—enVVeno Medical Corporation announced that it has received a not-approvable letter from the FDA in response to its premarket approval (PMA) application for VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). According to the company, the letter indicates that the FDA completed its review of the application and determined that it is unable to approve the PMA for the VenoValve…

FDA Rejects First-Ever Surgical Venous Valve Treatment: enVVeno's VenoValve Hits Regulatory Roadblock

FDA cites insufficient efficacy data and safety concerns for VenoValve in treating chronic venous insufficiency. Device targeted 2.5-3.5M US patients with severe CVI. Company exploring resubmission options.