Pi-Cardia specializes in innovative solutions for treating structural heart disease, particularly through their unique portfolio of leaflet modification technologies. Their flagship product, the Leaflex™ Performer, is a non-implant based, transfemoral catheter designed specifically for aortic stenosis. This device aims to modify leaflet calcification, enhancing leaflet mobility and significantly improving blood flow through the aortic valve. The procedure is characterized by its simplicity, safety, and affordability, which allows for shorter hospital stays and broader accessibility across various healthcare markets.

The Leaflex™ technology employs advanced methodologies, including Finite Elements Analysis, to optimize the design and efficacy of the treatment. This analysis helps identify the best scoring locations on the leaflets, which are crucial for restoring their natural movement and function. Bench tests conducted on ex-vivo human valves have shown that creating scoring lines along the leaflets' natural folding lines can effectively increase their pliability, thereby improving the valve opening area. Overall, Pi-Cardia's approach addresses significant unmet needs in the treatment of aortic stenosis, as demonstrated by the promising outcomes from their clinical investigations.

Israel

Pi-Cardia is a medical device company and market leader in the development of a broad portfolio of leaflet modification solutions for treating heart valves. The company has years of knowledge and expertise accumulated in degenerated valves, including calcification patterns, mode of valve failure, and impact of various methods of leaflet modification. ShortCut™ is designed to provide a safe, simple, and effective way to split leaflets of a pre-existing valve to enable TAVR in patients at risk for coronary obstruction and may assist in preserving coronary access.

Pi-Cardia

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