Non-Implant Based Leaflex™ Catheter First-in-Human Study Results

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Pi-Cardia Ltd. announced today that it successfully completed its First-in-Human study demonstrating substantial improvement in valve function following treatment with its Leaflex™ Performer catheter. The Leaflex™ Performer is a transfemoral catheter that uses two unique mechanical structures for scoring valve calcification at multiple locations, restoring leaflets flexibility and improving valve hemodynamics. The Leaflex™ catheter is intended to be a cost-effective durable standalone treatment or a preparatory step for improving the outcome of valve implantation in heavily calcified aortic valves. Prof. Andreas Baumbach from BARTs Hospital in London UK, the study PI, presented the study results today at the EuroPCR meeting in Paris, the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

The First-In-Human study aimed to demonstrate safety, feasibility and acute performance of the Leaflex™ catheter as a standalone treatment, and included sixteen (16) transfemoral cases where Leaflex™ was used prior to TAVR. Study investigators included Prof. Andreka (Budapest, Hungary), Prof. Baumbach (London, UK), Prof. Hildick-Smith (Brighton, UK), Prof. Bartus (Krakow, Poland), Dr. Mylotte (Galway, Ireland) and Dr. Jonas (Rehovot, Israel).

The study successfully demonstrated the safety and feasibility of the Leaflex™ scoring mechanism of action. Most importantly, the hemodynamic improvement post treatment, as measured by both echo and invasive techniques was significant and substantially greater than what has been previously reported with balloon valvuloplasty. “We were really happy to learn that a safe and simple procedure that takes less than 20 minutes can produce such a dramatic effect on valve function without leaving an implant behind. With these promising First in Human data, we can now move on to the next set of trials to show long term durability of the effect” says Dr. Peter Andreka from Budapest, Hungary, co-PI in the study. “We believe that if a simple, low-cost alternative existed, which could offer patients a reasonable period of time without symptoms, such a technique could have an important role alongside TAVR.”



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