Pi-Cardia has concluded the patient enrolment of the pivotal study of its ShortCut device, which is part of the company’s leaflet modification product portfolio.
ShortCut is claimed to be the world’s first dedicated device designed for splitting the leaflets of pre-existing valves to facilitate safe transcatheter aortic valve replacement (TAVR) in patients with a risk of coronary obstruction.
The study took place at 20 TAVR centres in Europe and the US.
It was led by doctors Susheel Kodali (New York Presbyterian/Columbia University, New York, US), Danny Dvir (Sha’are Zedek, Jerusalem, Israel) and Didier Tchétché (Clinique Pasteur, Toulouse, France).
The trial involved 60 subjects undergoing valve-in-valve procedures. ShortCut was used in these patients as a preceding step to TAVR implantation.
Central echo and CT core labs independently analysed the data.
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Pi-Cardia CEO Erez Golan said: “We are thrilled to have completed enrolment months ahead of schedule.
“This milestone not only validates our market models predicting a significant percentage of TAVR patients in need of leaflet modification, but it also means we should be able to commercialise ShortCut in the US and Europe as soon as 2024.”
The company’s leaflet modification product portfolio also includes the ShortCut Mitral to split leaflets in patients who are at risk of left ventricular outflow tract obstruction following TMVR.
Leaflex, also part of the portfolio, is a standalone, non-implant-based mechanical scoring device for restoring leaflet mobility and improving haemodynamics for aortic stenosis patients. Global clinical trials of Leaflex are currently in progress.