Skip to main content
  • 4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies

    MINNEAPOLIS, May 8, 2024 /PRNewswire/ -- 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.

This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies. Review our Privacy Policy for more details