Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™
Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.