Pi-Cardia’s ShortCut Device Receives FDA Breakthrough Device Designation

January 22, 2024—Israel-based Pi-Cardia Ltd. announced it received FDA Breakthrough Device designation for the company’s ShortCut device, a dedicated leaflet-modification device that facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction.

In September 2023, the company announced completion of enrollment in the ShortCut pivotal study in the United States and Europe.

“Having been part of Pi-Cardia’s rigorous clinical program, I am thrilled to see the recognition in the importance of ShortCut,” commented Philippe Généreux, MD, in the company’s press release.

Dr. Généreux, who is with Morristown Medical Center in Morristown, New Jersey, continued, “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 preimplantation so that patients at risk of coronary obstruction will be safely treated, without disruption of TAVR workflow.”

The company stated that 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 after transcatheter mitral valve replacement, and Leaflex, a standalone, non–implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Leaflex global clinical trials are underway. Additional leaflet-modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. ShortCut and Leaflex are investigational devices, limited by United States law for investigational use, advised the company.