Abbott Receives FDA Approval for First Device to Treat Heart Valve Leaks Without Open-Heart Surgery

Abbott has announced U.S. FDA approval for its Amplatzer™ Paraclose PVL Occluder, a transcatheter device designed to treat paravalvular leak (PVL) after heart valve replacement. This is the first and only device approved in the U.S. for this purpose, offering a minimally invasive alternative to repeat open-heart surgery for patients experiencing blood backflow around a surgical heart valve.