Thubrikar Aortic Valve has received approval from a Competent Authority in Poland to conduct initial patient implants with its Optimum transcatheter aortic valve implantation (TAVI) system. The company will sponsor this CE Mark-enabling pilot study on patients with severe aortic stenosis and begin to implant the first five patients in early 2022.
According to a press release from Thubrikar, Optimum TAV is the shortest profile valve among self-expanding transcatheter aortic valves, and its short profile facilitates coronary access. The company has designed a second-generation delivery catheter—the Precision 2 Catheter.
Mano Thubrikar, inventor of the Optimum transcatheter aortic valve and the company’s founder and president, stated: “We are thankful to our engineers and medical advisors for this progress. Durability remains the key issue in TAVI—younger patients still require open-heart surgery because no approved transcatheter aortic valves have demonstrated the durability of surgical valves. We designed the Optimum transcatheter aortic valve after the natural aortic valve because we discovered that it has the optimal geometry for efficient performance and durability. We also ensured that Optimum transcatheter aortic valve’s leaflets do not contain suture holes. As a result, Optimum transcatheter aortic valve has unparalleled durability and will greatly benefit patients.”
Susheel Kodali, director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center (New York, USA), and Mathew Williams, director of the Heart Valve Center at NYU Langone Health (New York, USA), have been important advisors for the company and have helped inspire the changes to the delivery catheter, the press release adds. They will continue to support the company in its clinical trials.