enVVeno Receives Unfavorable Appeal Decision from the FDA for the VenoValve

Core Viewpoint - enVVeno Medical Corporation has received an unfavorable decision from the FDA regarding its VenoValve® application, which indicates that the product does not meet the necessary safety and effectiveness standards [1] Company Summary - enVVeno Medical Corporation focuses on developing treatments for deep venous disease [1] - The company aimed to gain Premarket Approval (PMA) for its VenoValve®, a surgical replacement venous valve designed for severe deep chronic venous insufficiency (CVI) [1] Regulatory Summary - The FDA issued a not-approvable letter on August 19, 2025, which was upheld in a supervisory appeal [1] - The decision indicates that the VenoValve® failed to provide reasonable assurance of safety and effectiveness [1]