Pi-Cardia's ShortCut™ Receives FDA Breakthrough Device Designation as First-of-Its-Kind Technology

Pi-Cardia, a prominent figure in the development of non-implant, catheter-based solutions for heart valve treatments, has recently been granted Breakthrough Device Designation by the US Food and Drug Administration for its innovative ShortCut™ device. This device is a pioneering leaflet modification tool designed specifically for facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients who face a risk of coronary obstruction.

The management of aortic stenosis over a patient's lifetime often requires solutions like ShortCut™ to address the risk of coronary obstruction prior to valve implantation. ShortCut™ stands out for its potential to become an essential pre-implantation step in TAVR centers worldwide due to its ease of use and procedural effectiveness, ensuring the safe treatment of high-risk patients without disrupting workflow.

The Breakthrough Device Designation, which is awarded to devices with the potential to significantly improve the treatment or diagnosis of life-threatening or debilitating conditions, underscores the importance of ShortCut™ within Pi-Cardia's portfolio of leaflet modification products. In addition to ShortCut™, Pi-Cardia's portfolio includes ShortCut™ Mitral, designed for patients at risk of left ventricular outflow tract obstruction post-TMVR, and Leaflex™, a standalone mechanical scoring device aimed at enhancing leaflet mobility and hemodynamics for patients with aortic stenosis. Global clinical trials for Leaflex™ are currently underway.


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