Pi-Cardia’s ShortCut Leaflet Modification Device for TAVR Used in First Commercial Procedures

March 3, 2025—Pi-Cardia Inc., an Israel-based developer of leaflet modification solutions for treating heart valves, announced the first commercial procedures with the company’s ShortCut leaflet modification device for enabling valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. In September 2024, the company announced FDA clearance to market the ShortCut device in the United States.

According to the company, the initial ShortCut procedures were performed by Philippe Généreux, MD, and Gennaro Giustino, MD, at Gagnon Cardiovascular Institute in Morristown, New Jersey; Raj Makkar, MD, and Wen Cheng, MD, at Cedars-Sinai Medical Center in Los Angeles, California; and Vinod H. Thourani, MD, and Pradeep Yadav, MD, at Piedmont Heart Institute in Atlanta, Georgia.

“We are honored to have performed the first commercial ShortCut procedure and to be at the forefront of the innovative field of leaflet modification,” commented Dr. Généreux in Pi-Cardia’s press release. “In the past, treating this challenging patient population was possible mainly with surgical approaches or complex techniques. With ShortCut, we safely split both the right coronary cusp and left coronary cusp leaflets in a simple, predictable, and controlled manner, enabling safe placement of a TAVR.”

Dr. Makkar added, “The ShortCut device is a true game changer, addressing one of the most significant challenges in structural heart. It will play a fundamental role in the lifetime management of aortic stenosis patients who may require multiple valve interventions. Given its quick and intuitive nature and seamless integration into the standard TAVR workflow, I am confident this tool will become highly adoptable across TAVR centers.”

Also in the company’s press release, Drs. Yadav and Thourani stated, “ShortCut is transforming the way we approach patients with aortic stenosis. For intermediate- and high-risk patients who would have otherwise undergone surgery, it provides a reliable and predictable transcatheter option to prevent coronary obstruction. Thinking beyond the valve, we are now considering the necessary steps before implantation, as this will directly impact future treatment options for these patients.”