4C Medical’s AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies
May 8, 2024 — 4C Medical Technologies, Inc. (“4C Medical”), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for the AltaValve System, a transcatheter mitral valve replacement (TMVR) device. Among other benefits, Breakthrough Device designation expedites the review process, shortening the time until technology reaches patients if approved by the FDA. Specifically, the FDA granted the AltaValve System Breakthrough Device designations for two therapeutic indications: Treatment of moderate-to-severe or severe mitral regurgitation (MR), and Treatment of moderate-to-severe or severe MR with moderate/severe mitral annular calcification (MAC). MR occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts. If left untreated, MR can lead to heart failure or death. Due to the complexity