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FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR

Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device.

ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel-based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September.

The leaflet modification system addresses the risk of coronary obstruction before implanting a valve without disrupting TAVR workflow. Pi-Cardia’s leaflet modification portfolio also includes the ShortCut Mitral for splitting leaflets following TMVR. Its Leaflex standalone, non-implant-based mechanical storing device restores leaflet mobility and improves hemodynamics.

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