Thubrikar Aortic Valve Completes Initial CE Mark-Enabling TAVI-1 Study
NORRISTOWN, Pa. — (BUSINESS WIRE) — Thubrikar Aortic Valve, Inc., announced today that it has completed the initial CE Mark-enabling study using the Optimum Transcatheter Aortic Valve (Optimum TAV™) in patients with severe aortic stenosis. The implantations were performed by the Principal Investigator, Jaroslaw Trebacz, MD, at the Specialty Hospital Jana Pawla II in Krakow, Poland. The 5-patient study was approved by the Competent Authority of Poland, conducted in accordance with EU MDR, and monitored by the Company’s CRO, KCRI.
Valve performance has been outstanding, with single digit mean gradients and effective orifice areas (EOAs) better than most commercially available TAVR valves. “With over 14 years of my personal TAVR experience with all CE-marked devices, I now start to believe that Optimum TAV has the potential to combine the advantages of both a balloon- and a self-expandable valve,” commented Dr. Trebacz.
Optimum TAV is the only short-profile, self-expanding TAV in the TAVR field, thus providing easy coronary access as well as the benefits of a self-expanding valve. It is designed to mimic the natural aortic valve with dimensional proportionality and leaflet surface geometry, no suture holes in the flexion zone of the leaflet, and a unique anti-calcification treatment.
Optimum TAV has shown pre-clinical durability up to 24 years, with less calcification than established bioprosthetic surgical heart valves. Optimum TAV is intended to meet the needs of a younger patient population requiring a long-lasting valve with excellent hemodynamic performance. In Brazil, the first patient implanted with Optimum TAV continues to do well at 4 years.
“We are delighted with these initial results of 1-month and 6-month outcomes. These were truly ‘real world’ patients including those with a horizontal aorta, eccentric or no calcium burden, and a small aortic annulus. The unique short frame and self-expanding technology of the Optimum TAV performed very well in this complex group of patients, and we look forward to expanding enrollment throughout Europe to obtain CE Mark approval,” said Dr. Mano Thubrikar, Optimum TAV’s inventor, and the Company’s President and Founder. From the Company, Vishal Thubrikar, MD, Ali Recber, and Evan Roush were also present for the study.
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., are long-standing advisors and trial consultants for the Company, including for the development of its 2nd-generation delivery catheter – the Precision 2™ Catheter – which will provide repositionability and retrievability to the Optimum TAV, further optimizing the valve’s long-term success. 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 near Philadelphia, 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 Center 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.