Thubrikar Aortic Valve Announces Authorization to Initiate Patient Implants Toward CE Mark Approval of Optimum TAV, and Development of Its Novel Precision 2 Delivery Catheter
NORRISTOWN, Pa. — (BUSINESS WIRE) — Thubrikar Aortic Valve, Inc., announced today that it 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.
Optimum TAV™ is the shortest profile valve among self-expanding TAVs, and its short profile facilitates coronary access. The Company has designed a 2nd-generation delivery catheter – the Precision 2™ Catheter – making Optimum TAV repositionable, recapturable, and retrievable during the TAVI procedure. Optimum TAV’s short frame reorients as it is deployed in the diseased valve which results in axial alignment of the valve. The Precision 2 Catheter, with its repositionability, provides good control during valve deployment and axial alignment.
Additionally, the Optimum TAV demonstrated the equivalent of over 24 years’ durability in bench testing, and showed less calcification than even surgical valves in extended animal implants. With the next-generation delivery catheter and enhanced valve durability, the Optimum TAVI System will be the system of choice for aortic valve replacement, particularly for younger patients. The first patient implanted with Optimum TAV continues to do well at three years.
Dr. Mano Thubrikar, inventor of the Optimum TAV 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 TAVs have demonstrated the durability of surgical valves. We designed the Optimum TAV after the natural aortic valve because we discovered that it has the optimal geometry for efficient performance and durability. We also ensured that Optimum TAV’s leaflets do not contain suture holes. As a result, Optimum TAV has unparalleled durability and will greatly benefit patients.”
Dr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center, and Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health in the U.S., have been important advisors for the Company and have helped inspire the changes to the delivery catheter. They will continue to support the Company in its clinical trials.
Dr. Kodali is a recognized authority on percutaneous heart valves and his center was the lead investigational site for several of the large clinical trials that led to the approval of TAVI in the U.S. He has been an investigator for such clinical trials since 2007.
Dr. Williams is a widely recognized pioneer in transcatheter valve replacement and has conducted nearly 4,000 such procedures. He was the Lead Principal Investigator in the premarketing trials of self-expanding TAVs.
Drs. Williams and Kodali report disclosures with Thubrikar Aortic Valve, Inc.
About Thubrikar Aortic Valve and its Optimum TAVI System™
Thubrikar Aortic Valve, Inc. is a privately held medical device company based in Norristown, PA, that has developed a next-generation transcatheter aortic valve, the Optimum TAV, and delivery catheter, collectively called the “Optimum TAVI System.” Optimum TAV was designed after the natural aortic valve using 30 years of research by the Company’s Founder, Dr. Mano Thubrikar. He served as Director of Surgical Research at the University of Virginia, Director of Biomedical Engineering at the Heineman Medical Research Foundation in Charlotte, Distinguished Research Scientist at Edwards Lifesciences, and Director of Biomedical Engineering at the South Dakota School of Mines and Technology. He is the author of The Aortic Valve, a leading textbook covering the fundamentals of valve structure and function. For more information, please visit: www.tavi.us.