Pi-Cardia Earns Breakthrough Nod for ShortCut Leaflet Modification Device

Pi-Cardia, a developer of non-implant, catheter-based leaflet modification solutions to treat heart valves, has earned breakthrough status from the U.S. Food and Drug Administration (FDA) for ShortCut.
 
ShortCut is a dedicated leaflet modification device to facilitate valve-in-valve transcatheter aortic valve replacement (TAVR) in patients at risk of coronary obstruction. This announcement follows the finished enrollment in the ShortCut pivotal study in the U.S. and Europe in September 2023.
 
ShortCut Aortic was designed to split leaflets of a pre-existing valve prior to TAVR. The company said it may help to help to preserve coronary access.
 
“We are excited to receive this important recognition by the FDA,” said Erez Golan, Pi-Cardia’s CEO. “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.”
 
The company’s portfolio also includes ShortCut Mitral to split leaflets in patients at risk of left ventricular outflow tract obstruction after transcatheter mitral valve replacement (TMVR). Pi-Cardia also touts Leaflex, a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and boost hemodynamics for patients with aortic stenosis. Global clinical trials of Leaflex are currently underway.
 
“Having been part of Pi-Cardia’s rigorous clinical program, I am thrilled to see the recognition in the importance of ShortCut,” said Philippe Genereux, MD from Morristown Medical Center in N.J. “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. From what we have seen regarding the ability to easily teach and perform the procedure, ShortCut could be easily adopted by every TAVR center as a critical step pre-implantation, so that patients at risk of coronary obstruction will be safely treated, without disruption of TAVR work-flow.”