Pi-Cardia Receives FDA IDE Approval for Pivotal Study of ShortCut Valve Leaflet Splitting Device

July 26, 2022—Pi-Cardia Ltd. announced it received investigational device exemption (IDE) approval from the FDA to commence the ShortCut Pivotal Study, which will assess the safety and effectiveness of the company’s ShortCut device.

According to the company, the ShortCut device 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, potentially enhancing the safety of valve-in-valve procedures and expanding the TAVR market.

The United States ShortCut Study Principal Investigator is Susheel K. Kodali, MD, Director of Structural Heart & Valve Center at New York Presbyterian/Columbia University Medical Center in New York, New York.

In the company’s press release, Dr. Kodali commented, “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. When we then need to implant a second or third valve in a patient, the ShortCut device can simply split the leaflets of the previous valve and is designed to facilitate a safe TAVR.”

Dr. Kodali continued, “Procedures performed to date outside the United States demonstrate that ShortCut was able to effectively split the leaflets within minutes, allowing for a safe implantation of both self-expandable and balloon-expandable TAVR valves. We are so excited to join our European colleagues and start enrolling patients in the United States soon.”

ShortCut is part of the Pi-Cardia’s product portfolio, which also includes the Leaflex device—a standalone, nonimplant-based treatment for patients with aortic stenosis. Leaflex performs mechanical scoring of valve calcification and is designed to restore leaflet mobility and improve hemodynamics. Leaflex global clinical trials are underway. ShortCut and Leaflex are investigational devices, limited by United States law for investigational use, advised the company.