Pi-Cardia Inc. has announced the start of its first commercial procedures using the ShortCut device, a tool designed for leaflet modification in valve-in-valve (ViV) Transcatheter Aortic Valve Replacement (TAVR) procedures.
This development follows the recent clearance of ShortCut De Novo by the US Food and Drug Administration (FDA) in September 2024.
The ShortCut device offers a non-implant, catheter-based method for modifying heart valve leaflets. It is used to split existing valve leaflets before TAVR, targeting patients who are at risk for coronary obstruction while maintaining coronary access.
Additionally, ShortCut Mitral is intended to divide the anterior mitral leaflet before Transcatheter Mitral Valve Replacement (TMVR) in patients at risk for left ventricular outflow tract (LVOT) obstruction.
Pi-Cardia also offers the Leaflex device, which mechanically scores valve calcification at multiple sites to restore leaflet flexibility and improve valve hemodynamics.
Leaflex is aimed at treating calcified aortic stenosis. The company is working on additional leaflet modification technologies for complex anatomies like bicuspid valves.
Both Leaflex and ShortCut Mitral are investigational devices under US law, limited to investigational use.
Initial procedures with ShortCut were completed at several institutions, including the Gagnon Cardiovascular Institute in Morristown, New Jersey, Cedars-Sinai Medical Center in Los Angeles, California, and Piedmont Heart Institute in Atlanta, Georgia.
Pi-Cardia CEO Erez Golan said: “The first week of US 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.”
