Pi-Cardia’s ShortCut Leaflet-Splitting Device Used in First Procedure in United States in IDE Pivotal Study

December 19, 2022—Pi-Cardia Ltd., an Israel-based developer of nonimplant, catheter-based, leaflet modification solutions for treating heart valves, announced that the first patient in the United States has been successfully treated with the company’s ShortCut device. ShortCut is designed to split the leaflets of a preexisting valve to enable safe transcatheter aortic valve replacement (TAVR) in patients at risk for coronary obstruction.

In July 2022, Pi-Cardia announced FDA approval of an investigational device exemption (IDE) to commence the ShortCut Pivotal Study. Multiple patients have been treated successfully outside the United States, noted the company.

The first ShortCut procedure in the United States was performed at Morristown Medical Center in Morristown, New Jersey, by Philippe Généreux, MD; Jim Slater, MD; Leo Marcoff, MD; and Robert Kipperman, MD, in collaboration with Benjamin Seguy, MD, who is with CHU de Bordeaux, France.

“We successfully treated this patient with a degenerated valve who was at risk of coronary obstruction after TAVR with the ShortCut device,” commented Dr. Généreux in Pi-Cardia’s press release. “The targeted leaflet was effectively split within just a few minutes, allowing for safe implantation of the TAVR valve. ShortCut is a real game changer enabling TAVR treatment in younger patients who will likely need multiple interventions over the course of their lives.”

Susheel K. Kodali, MD, who is Principal Investigator of the United States ShortCut Study, added, “Lifetime management for patients with aortic stenosis is increasingly important as we use bioprosthetic valves more frequently in younger patients, and these valves degenerate over time. Often times, we may need to implant multiple valves in a patient, which may entail a risk of coronary obstruction or lack of access. The ShortCut device can simply split the leaflets of the previous degenerated valve and is designed to facilitate a safe TAVR.” Dr. Kodali is Director of the Structural Heart & Valve Center at New York Presbyterian/Columbia University Medical Center in New York, New York.

Erez Golan, Pi-Cardia’s Chief Executive Officer, stated in the press release, “We are very pleased with this milestone of commencing enrollment in the United States, which allows us to move forward with our clinical plan towards commercialization in the United States and Europe. Given the enthusiasm from United States clinicians, we believe ShortCut can be the first dedicated leaflet-splitting device coming to market as early as 2024.”

ShortCut is part of Pi-Cardia’s leaflet modification product portfolio that includes the ShortCut Mitral, which is for splitting leaflets in patients at risk for left ventricular outflow tract obstruction after transcatheter mitral valve replacement, and Leaflex, a standalone, nonimplant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Leaflex global clinical trials are underway. ShortCut and Leaflex are investigational devices limited by United States law for investigational use, advised the company.