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.
Source: https://www.businesswire.com/news/home/20240122184265/en/Pi-Cardia-Receives-FDA-Breakthrough-Device-Designation-for-ShortCut%E2%84%A2
