Pi-Cardia has recently started its first-in-human study with its Leaflex Performer catheter system. According to a press release, the Leaflex Performer is a transfemoral catheter that uses two unique mechanical structures for scoring valve calcification at multiple locations, designed to restore leaflets flexibility and improving valve haemodynamics.
The press release reports that the Leaflex catheter is aimed to be a cost-effective standalone treatment or a preparatory step for improving the outcome of valve implantation in heavily calcified aortic valves, bicuspid aortic valves and calcified mitral valves. Initial trial results demonstrate safety, feasibility and a hemodynamic improvement, which is significantly superior to that previously achieved with balloon valvuloplasty.
The design of the Leaflex Performer was based on the company’s extensive research on calcium growth patterns in thousands of human aortic valves. Pi-Cardia’s Leaflex technology and mechanism of action are fundamentally different from those of balloon-based devices, in that instead of simply dilating the valve, which might lend itself to the short-term recoil seen in patients treated with balloon valvuloplasty, the Leaflex scores the leaflets to create multiple targeted fractures at optimal locations of valve calcification thereby restoring leaflet mobility. This unique scoring method, while preserving the native valve integrity, may facilitate valve replacement therapies, as well as pave the way for providing durable treatment without implanting a new valve.
Krzysztof Bartus (Department of Cardiovascular Surgery and Transplantation, Jagiellonian University, John Paul II Hospital, Krakow, Poland), who with Boguslaw Kapelak, performed the first-in-human cases with the Leaflex catheter, notes: “In a typical case of an eighty-five-year-old patient with a tri-leaflet aortic valve, we will simply have more options to offer, and there are also some common anatomies such as bicuspid aortic valves, where TAVI delivers suboptimal results. We believe that if a simpler, lower-cost alternative existed, which could offer patients a reasonable period of time without symptoms, such a technique could have an important role alongside TAVI.”
Erez Golan, Pi-Cardia’s Founder and CEO, comments: “As much as transcatheter aortic valve implantation (TAVI) improves and becomes a routine procedure in lower surgical risk patients, it is still an implant with unknown durability, so in young patients taking a more conservative approach of using Leaflex to defer TAVI may make a lot of sense. TAVI is @ budget sensitive environment, waiting lists for TAVI are common even in the most developed countries, let alone in emerging markets, where TAVI may not be a viable option for most patients.”
Pi-Cardia will present the Leaflex catheter system and initial clinical results at the 2018 EuroPCR meeting (21–25 May, Paris, France).