First Dedicated Leaflet Modification Device Enables TAVR in Patients at Risk of Coronary Obstruction

The field of Transcatheter Aortic Valve Replacement (TAVR) faces a number of unmet challenges. For instance, degenerated valves that require reintervention present a risk of coronary obstruction and coronary access impairment. Moreover, TAVR procedures in native valves present a risk of coronary impairment in a select group of patients. Now, the world’s first dedicated transcatheter leaflet splitting device can enable coronary access and prevent coronary obstruction during TAVI. Designed for safe, simple splitting of single or double leaflets, with short procedural times, it provides complete control over positioning and leaflet splitting location.

Pi-Cardia Ltd.’s (Rehovot, Israel) ShortCut is the world's first dedicated leaflet modification device facilitating valve-in-valve TAVR procedures in patients at risk of coronary obstruction. ShortCut is part of Pi-Cardia's leaflet modification product portfolio, which also includes the ShortCut Mitral for splitting leaflets in patients at risk for left ventricular outflow tract obstruction following Transcatheter Mitral Valve Replacement (TMVR). Pi-Cardia's ShortCut device is designed to provide a safe, simple, and effective way to split valve leaflets: ShortCut Aortic is designed to split leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction and may assist in preserving coronary access; ShortCut Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction.

Lifetime management of aortic stenardia has received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut and has completed enrollment in the ShortCut Pivotal Study in the US and Europe.

“We are excited to receive this important recognition by the FDA,” said Erez Golan, Pi-Cardia's Chief Executive Officer. “Breakthrough Device Designation is only awarded to technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversible debilitating diseases or conditions, and it may help accelerate our review process with the FDA this year and bring ShortCut to market for the benefit of patients.”