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

VERITAS Vision System Is Introduced by Johnson & Johnson

The company will offer live demos of the new system in a wet lab at the Johnson & Johnson booth (#2813) this weekend at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting.

GenesisCare Orders 27 Elekta Flexitron Treatment Devices

"GenesisCare continues to demonstrate its commitment to improving patient outcomes worldwide and Elekta is delighted to play a vital partnering role to achieve this mission," said Gustaf Salford, Elekta's President and CEO.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

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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