Rehovot, Israel-based Pi-Cardia designed ShortCut to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after transcatheter aortic valve replacement (TAVR) or left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR).

ShortCut enables valve-in-valve TAVR procedures in patients at risk of coronary obstruction. The company says it represents the world’s first dedicated device designed to split the leaflets prior to valve treatment. FDA clearance comes just over two years after the first-in-human procedures conducted with ShortCut in Germany.