Pi-Cardia Ltd. | MedPath

FDA Clears Pi-Cardia's ShortCut Device for Valve-in-Valve TAVR Procedures

8 months ago

• Pi-Cardia's ShortCut device receives FDA clearance to reduce coronary obstruction risk during valve-in-valve transcatheter aortic valve replacement (TAVR). • The ShortCut device mechanically splits aortic valve leaflets before valve placement, differing from electrosurgery-based methods like the BASILICA procedure. • Clinical data demonstrated ShortCut's safety and effectiveness in leaflet splitting, making it a teachable step in TAVR to safely treat patients at risk of coronary obstruction. • Pi-Cardia plans a limited commercial launch of ShortCut, with future expansions potentially covering 30% of TAVR cases requiring leaflet modification.