Thubrikar’s Optimum TAV Device Evaluated at 30 Days in TAVI-1 Study to Enable CE Mark Approval

August 2, 2022—Thubrikar Aortic Valve, Inc., announced the 30-day outcomes in the first two patients receiving transcatheter aortic valve implantation (TAVI) with the company’s Optimum TAV device in the TAVI-1 study. Three more patients in the study are expected to receive the Optimum TAV in the coming weeks.

The study is being conducted to enable CE Mark approval of the device, noted the company, which is headquartered near Philadelphia, Pennsylvania.

The implantations were performed by the study’s 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 the European Union Medical Device Regulation. In December 2021, the company announced approval of the CE Mark-enabling study.

Mathew Williams, MD, Director of the Heart Valve Center at NYU Langone Health in New York, New York, proctored the implantation team of an interventional cardiologist and a cardiac surgeon.

Dr. Williams and Susheel Kodali, MD, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center in New York, New York have been the company’s Medical Advisors since its founding in 2010. They will continue to support the company in its clinical trials.

According to the company, both first two 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 at 3 months after implantation. The patients’ quality of life has also improved significantly.

The company stated that the short-profile, self-expanding Optimum TAV’s performance has been outstanding, with postimplantation mean gradients and EOAs exceeding most commercially available TAVI valves. The device 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 anticalcification treatment.

With demonstrated preclinical 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, advised the company.

Mano Thubrikar, PhD, inventor of the Optimum TAV and the company’s Founder and President, commented in the press release, “We are grateful to Drs. Trebacz and Williams, and the entire team, for the success in the first two patients. Optimum TAV has unparalleled preclinical durability, and we plan to bring this technology to more patients soon.”