Tuesday, January 23, 2024
Pi-Cardia, a well-established global developer specializing in catheter-based solutions for heart valve treatment without the need for implants, has announced the receipt of the Breakthrough Device Designation from the Food and Drug Administration for its innovative ShortCut™. Positioned as the world's pioneering cusp modification device designed for transcatheter aortic valve replacement (TAVR) procedures, ShortCut™ addresses the crucial challenge of coronary artery obstruction in high-risk patients.
The effective management of aortic stenosis over a patient's lifetime necessitates precise cusp modification solutions, and ShortCut™ stands out in this regard. The device ensures a comprehensive assessment of the risk of coronary artery obstruction before valve implantation. The potential simplicity of teaching and performing the procedure suggests that ShortCut™ could become an indispensable preliminary phase in TAVR centers, facilitating safe treatment for patients at risk of coronary artery obstruction without disrupting the TAVR workflow.
The Breakthrough Device Designation, granted to technologies showing promise for more effective diagnosis or therapy for serious conditions, aims to expedite the ongoing FDA review. The goal is to bring ShortCut™ to market this year, delivering significant benefits for patients.
ShortCut™ is part of Pi-Cardia's cusp modification product portfolio, which includes ShortCut™ Mitral—intended for separating valve leaflets in patients at risk of left ventricular outflow tract obstruction post transcatheter mitral valve replacement (TMVR)—and Leaflex™, a non-implant, self-contained mechanical valve decalcification device. Leaflex™ is developed to restore cusp flexibility and enhance blood circulation in individuals with aortic stenosis, currently undergoing global clinical trials.
Source: businesswire.com
