Thubrikar Aortic Valve has announced 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, at the Specialty Hospital Jana Pawla II, Krakow, Poland. The study was approved by the Competent Authority of Poland and conducted in accordance with European Union (EU) Medical Device Regulations (MDR). Mathew Williams (NYU Langone Health, New York, 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 transcatheter aortic valve implantation (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 three months following implantation. Their quality of life has also improved significantly.
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 two patients. Optimum TAV has unparalleled pre-clinical durability, and we plan to bring this technology to more patients soon.”
Williams and Susheel Kodali (New York-Presbyterian/Columbia University Medical Center, New York, USA) have been the company’s medical advisors since its founding. They will continue to support the company in its clinical trials.