Pi-Cardia’s ShortCut Leaflet Modification Device for TAVR Cleared by FDA

September 30, 2024—Pi-Cardia Ltd., an Israel-based developer of leaflet modification solutions for treating heart valves, announced FDA clearance to market the company’s ShortCut in the United States.

According to the company, ShortCut is a dedicated leaflet modification device that enables valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction.

Martin B. Leon, MD, chairs the global steering committee for ShortCut studies.

“Lifetime management of aortic stenosis calls for leaflet modification solutions like ShortCut to ensure that we are carefully addressing the risk of coronary obstruction before implanting a valve,” commented Dr. Leon in Pi-Cardia’s press release. “The rigorous pivotal study leading to this important market clearance by the FDA demonstrates that ShortCut was both safe and effective in achieving the intended leaflet split in all patients.”

Dr. Leon continued, “Importantly, it also shows that mechanical splitting with ShortCut—in both single- and dual-leaflet cases—was a controlled and teachable procedure, making it adoptable by TAVR centers as a critical step pre-implantation, so that patients at risk of coronary obstruction may be safely treated without disruption of TAVR workflow.”

Dr. Leon is director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons in New York, New York.