Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™
Pi-Cardia Ltd., a prominent player in advancing catheter-based leaflet modification solutions for heart valve treatment, revealed that its ShortCut™ device has attained Breakthrough Device Designation from the US Food and Drug Administration. ShortCut™, recognized as the world's inaugural device tailored for leaflet modification, is designed to aid valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures for patients susceptible to coronary obstruction. This milestone follows the conclusion of the ShortCut™ Pivotal Study's enrollment in the US and Europe in September 2023.
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