Thubrikar Aortic Valve Announces Initial 30-Day Outcomes of CE Mark-Enabling TAVI-1 Study
NORRISTOWN, Pa. — (BUSINESS WIRE) — Thubrikar Aortic Valve, Inc., announced today successful 30-day outcomes in the first two patients receiving the Optimum Transcatheter Aortic Valve (Optimum TAV™). The implantations were performed by the Principal Investigator, Jaroslaw Trebacz, MD, at the Specialty Hospital Jana Pawla II in Krakow, Poland. The study was approved by the Competent Authority of Poland and conducted in accordance with EU MDR. Mathew Williams, MD, Director of the Heart Valve Center at NYU Langone Health, USA, proctored the implant team of an interventional cardiologist and a cardiac surgeon. Three more patients are expected to receive the Optimum TAV in the coming weeks.
The procedures were conducted using the Minimalist TAVI approach. Both patients showed significant clinical improvement as evidenced by quantitative improvements in valvular pressure gradients and effective orifice areas (EOAs). The patients met all primary outcome measures and were free from all-cause mortality, stroke, major bleeding, pacemaker implantation, moderate to severe regurgitation, and vascular complications 3 months following implantation. Their quality of life has also improved significantly.
Valve performance has been outstanding, with post-implant mean gradients and EOAs exceeding most commercially available TAVR valves. 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’s dimensional proportionality and leaflet surface geometry. It has no suture holes in the flexion zone of the leaflet and a unique anti-calcification treatment. The Optimum TAV has shown pre-clinical durability up to 24 years in addition to less calcification than an established bioprosthetic surgical heart valve. The Optimum TAV is intended to meet the needs of a younger patient population requiring a long-lasting valve with excellent hemodynamic performance.
Dr. Mano Thubrikar, inventor of the Optimum TAV and the company’s Founder and President, stated, “We are grateful to Drs. Trebacz and Williams, and the entire team, for the success in the first 2 patients. Optimum TAV has unparalleled pre-clinical durability, and we plan to bring this technology to more patients soon.”
Mathew Williams, MD, and Susheel Kodali, MD, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center have been the company’s Medical Advisors since its founding. They will continue to support the company in its clinical trials.
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 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 to mimic the natural aortic valve using 30 years of research by the company’s Founder, Dr. Mano Thubrikar. 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.