Pi-Cardia has introduced an innovative breakthrough known as ShortCut™, targeting the treatment of patients facing a high risk of coronary obstruction.
This groundbreaking device is hailed as the world's first dedicated leaflet modification tool, designed to streamline valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in such high-risk patients.
ShortCut™ offers a seamless integration into TAVR centres worldwide, serving as a pivotal pre-implantation step. Its adoption ensures the safe and uninterrupted treatment of patients vulnerable to coronary obstruction during TAVR procedures.
ShortCut™ stands as a cornerstone within Pi-Cardia's comprehensive leaflet modification product portfolio. This portfolio encompasses ShortCut™ Mitral, a solution tailored for patients at risk of left ventricular outflow tract obstruction post-Transcatheter Mitral Valve Replacement (TMVR).
Additionally, Pi-Cardia offers Leaflex™, an autonomous mechanical scoring device designed to enhance leaflet mobility and optimise haemodynamics in patients suffering from aortic stenosis. Currently, global clinical trials for Leaflex™ are underway, underscoring Pi-Cardia's commitment to advancing cardiovascular care through innovative solutions.
Pi-Cardia announced that it has received breakthrough device designation from the US food and drug administration for ShortCut™ in patients at risk of coronary obstruction.