Pi-Cardia has announced a successful first-in-human treatment of the mitral valve with the ShortCut Mitral device in Europe.
ShortCut is a dedicated device designed to split the leaflets prior to transcatheter valve treatment in patients at risk for coronary obstruction after transcatheter aortic valve implantation (TAVI) 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, Eppendorf, Germany by Lenard Conradi and Niklas Schofer, in collaboration with Paolo Denti (San Raffaele Hospital, Milan, Italy). “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.”
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 Denti. “I believe that ShortCut Mitral provides a solution that may almost double the number of patients eligible for TMVR.”
ShortCut Mitral joins Pi-Cardia’s product portfolio, which includes the ShortCut Aortic for splitting leaflets in patients at risk for coronary obstruction after TAVI, and the Leaflex—a standalone, non-implant-based mechanical scoring device to restore leaflet mobility and improve haemodynamics for patients with aortic stenosis. Both devices are currently undergoing clinical trials in Europe, and enrolment is planned to start in the USA in the next few months.