The Boston-based company designed ShortCut to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after transcatheter aortic valve replacement (TAVR) or left ventricular outflow tract (LVOT) obstruction after transcatheter mitral valve replacement (TMVR).
ShortCut enables valve-in-valve TAVR procedures in patients at risk of coronary obstruction. The company says it represents the world’s first dedicated device designed to split the leaflets prior to valve treatment. Pi-Cardia won FDA clearance for the ShortCut device in September 2024.
The first procedures took place at various institutions across the U.S. Those include the Gagnon Cardiovascular Institute (Morristown, New Jersey), Cedars-Sinai Medical Center (Los Angeles) and Piedmont Heart Institute (Atlanta). Dr. Philippe Généreux and Dr. Gennaro Giustino (Gagnon), Dr. Raj Makkar and Dr. Wen Cheng (Cedars) and Dr. Vinod H. Thourani and Dr. Pradeep Yadav (Piedmont) performed them.
“In the past, treating this challenging patient population was possible mainly with surgical approaches or complex techniques. With ShortCut, we safely split both the RCC and LCC leaflets in a simple, predictable, and controlled manner, enabling safe placement of a TAVR,” said Généreux.
More about the Pi-Cardia ShortCut device
Makkar called ShortCut a “true game-changer” that addresses “one of the most significant challenges in structural heart.” Yadav and Thourani say ShortCut delivers a “reliable and predictable transcatheter option to prevent coronary obstruction.”
According to Pi-Cardia, as bioprosthetic valves degenerate over time, patients may need a valve-in-vale procedure. A significant portion at risk for coronary obstruction would then require leaflet splitting with ShortCut.
Pi-Cardia expects future planned indication expansion into native and bicuspid valves to lead to around 30% of future TAVR cases requiring leaflet modification with ShortCut to perform the replacement safety and garner optimal results for patients.
“We are incredibly proud of this significant milestone and are excited to pioneer the leaflet modification market,” said Erez Golan, Pi-Cardia CEO. “The first week of U.S. launch demonstrated strong demand across the country for ShortCut, with several leading hospitals treating patients successfully, and many other recognized institutes, including Tucson Medical Center, Kaiser San Francisco, Los Robles Regional Medical Center, University of Michigan, and Sentara Norfolk General Hospital, expected to join in the coming weeks.
“We continue to build our highly skilled field team and further increase manufacturing capacity as we partner closely with physicians and hospital systems to ensure they have access to ShortCut.”
