FIH Studies Completed for Pi-Cardia's Leaflex Performer Catheter to Treat Aortic Stenosis
May 7, 2019—Israel-based Pi-Cardia Ltd. announced the completion of first-in-human (FIH) studies with the company's Leaflex Performer catheter. Two sequential FIH studies were conducted to demonstrate the safety, feasibility, and device performance of the device.
The Leaflex catheter is aimed to be a cost-effective, durable, standalone treatment or a preparatory step for improving the outcome of valve implantation in heavily calcified and bicuspid aortic valves.
The first FIH study, conducted in Krakow, Poland, was a single-center intraoperative evaluation of five patients in whom Leaflex was used before surgical aortic valve replacement.
A second study included 16 transfemoral cases performed by leading transcatheter aortic valve replacement (TAVR) centers in Europe and Israel. The Leaflex device was used before the TAVR procedure to study the safety, feasibility, and acute improvement in valve hemodynamics.
Principal Investigator Professor Andreas Baumbach, MD, will present the Leaflex study results on May 22 during the Late Breaking Trials Session at the EuroPCR meeting, which will be held in Paris, France on May 21–4, 2019. Prof. Baumbach is with Barts Hospital in London, United Kingdom.
The transfemoral Leaflex Performer catheter uses two mechanical structures for scoring valve calcification at multiple locations. These scoring lines create separation between the calcium deposits in order to regain the leaflets' flexibility, allow their mobility, and improve valve hemodynamics.
The company advised that its Leaflex technology and mechanism of action are fundamentally different from those of balloon aortic valvotomy (BAV) devices. Instead of dilating the valve, which might result in short-term recoil seen in patients treated with BAV, Leaflex scores the leaflets to create multiple targeted fractures at optimal locations of valve calcification, thereby restoring leaflet mobility. This scoring method preserves the native valve integrity and may facilitate valve replacement therapies and allow for durable treatments without implanting a new valve, stated Pi-Cardia.