Pi-Cardia announced today that it completed a successful first-in-human treatment of the mitral valve with its ShortCut device.
Rehovot, Israel-based Pi-Cardia 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).
The company said in a news release that ShortCut represents the world’s first dedicated device designed to split the leaflets prior to valve treatment.
Prof. Lenard Conradi and Dr. Niklas Schofer, in collaboration with Dr. Paolo Denti, performed the ShortCut Mitral compassionate case at the University Hamburg Eppendorf, Germany.
“We were able to successfully treat a patient who was at risk of LVOT obstruction by effectively splitting the anterior leaflet in a simple and controlled manner prior to a TMVR procedure,” said Conradi. “With the ShortCut Mitral device, we will now be able to treat more patients with mitral valve disease who otherwise have no other option.”
Denti added that LVOT obstruction represents “a major limitation” in TMVR procedures, causing patients to screen fail. He said ShortCut mitral provides “a solution that may almost double the number of patients eligible for TMVR.”
ShortCut mitral joins Pi-Cardia’s product portfolio that includes the ShortCut aortic for splitting leaflets in patients at risk for coronary obstruction after TAVR and the Leaflex standalone, non-implant-based mechanical scoring device for restoring leaflet mobility and improve hemodynamics for patients with aortic stenosis.
Pi-Cardia’s ShortCut aortic and Leaflex devices are currently undergoing clinical trials in Europe, with U.S. enrollment slated for the coming months.
“We are thrilled to reach this important milestone that will eventually allow a significant number of patients with mitral valve disease to be treated less invasively” said Erez Golan, Pi-Cardia’s CEO. “We are making great progress demonstrating the feasibility of our leaflet modification technologies, namely ShortCut and Leaflex, while working on future technologies for treating significant new indications such as challenging bicuspid valves. We plan to be in the U.S. market with our first product in 2024.”