Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today a successful First-In-Human treatment of the mitral valve with the ShortCut™ Mitral device in Europe. ShortCut™ is the world’s first dedicated device designed 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 ShortCut™ Mitral compassionate case was performed at the University Hamburg Eppendorf, Germany, by Prof. Lenard Conradi and Dr. Niklas Schofer, in collaboration with Dr. Paolo Denti. “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 Prof. 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.”
The TMVR market is growing exponentially and is predicated to reach several billion dollars in the next decade. LVOT obstruction often occurs when the anterior mitral leaflet is displaced following TMVR and is associated with morbidity and mortality. “LVOT obstruction has been a major limitation for TMVR procedures, causing a significant number of patients to screen fail” said Dr. Paolo Denti, San Raffaele Hospital, Milan, Italy. “I believe that ShortCut™ Mitral provides a solution that may almost double the number of patients eligible for TMVR.”
ShortCut™ Mitral now joins Pi-Cardia’s product portfolio, which includes the ShortCut™ Aortic for splitting leaflets in patients at risk for coronary obstruction after TAVR, and the Leaflex™ – a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve hemodynamics for patients with aortic stenosis. Both devices are currently undergoing clinical trials in Europe, and enrollment is planned to start in the United States in the next few 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 Chief Executive Officer. “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 US market with our first product in 2024.”
Pi-Cardia is a global leader in the development of a unique portfolio of non-implant-based solutions for treating heart valves. Pi-Cardia’s ShortCut™ device is designed to provide a safe, simple and effective way to split valve leaflets: ShortCut™ Aortic is designed to split leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction; ShortCut™ Mitral is designed to split the anterior mitral leaflet prior to TMVR in patients at risk for LVOT obstruction. Pi-Cardia’s Leaflex™ device mechanically scores valve calcification at multiple locations, with the intention of restoring leaflet flexibility and improving valve hemodynamics. Leaflex™ is designed to be a cost-effective, durable standalone treatment for patients with calcified aortic stenosis. Additional leaflet modification technologies are being developed to further expand treatment options in challenging anatomies such as bicuspid valves. The ShortCut™ device and Leaflex™ device are investigational devices, limited by United States law for investigational use.
For more information, please visit: www.pi-cardia.net