Thubrikar Aortic Valve’s TAVI-1 CE Mark Trial Receives Expanded Authorization

December 15, 2023—Thubrikar Aortic Valve, Inc. announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the company’s Optimum TAV, a transcatheter aortic valve implantation/replacement (TAVI/TAVR) system.

The authorization allows for an additional 15 patients to be treated with the Optimum TAV device using the company’s Precision 2 second-generation delivery catheter.

The authorization also allows for an additional clinical site in Poland. The trial will now include patient implantations at both the Specialty Hospital Jana Pawla II in Krakow, and the University Clinical Hospital Jana Mikulicza-Radeckiego in Wroclaw.

According to the company, the Precision 2 catheter is engineered to provide operators with significant control. It allows the Optimum TAV system to be repositioned and recaptured for retrieval, if necessary, during the TAVI/TAVR procedure.

The catheter’s design allows the Optimum TAV’s short frame to reorient as it is deployed in the diseased valve, which results in automatic axial alignment of the valve. The Optimum TAV is less than half the height of commercial self-expanding platforms and allows full coronary access. It mimics the geometry and leaflet dynamics of the natural aortic valve and has no suture holes in the flexion zone, stated the company.

In October 2022, the company announced the completion of the initial study to support CE Mark approval for the Optimum TAV. The implantations were performed by principal investigator Jarosław Trębacz, MD, at the Specialty Hospital Jana Pawla II. In December 2021, the company announced that the Competent Authority of Poland approved the five-patient study.

The company advised that data from the first five patients in the TAVI-1 trial demonstrated extraordinary valve performance. Additionally, the patients have shown remarkable clinical improvement at 1 year, including freedom from all-cause mortality, stroke, and hospitalization for procedure- or valve-related causes, as well as increases in their Kansas City Cardiomyopathy Questionnaire scores, noted the company.

The Optimum TAV was implanted in the first patient in 2018 in Brazil by the company’s licensee, Labcor. Excellent valve hemodynamic performance and long-term clinical efficacy have now been demonstrated at 5 years, stated the company.

Mano Thubrikar, PhD, who is the inventor of the Optimum TAV device, is Founder and President of Thubrikar Aortic Valve. The privately held company is headquartered in Collegeville, Pennsylvania.

“We have completed 1-year follow-up on five patients in Poland, and the data on pressure gradient and effective orifice area of the Optimum TAV is superior to that published on any transcatheter aortic valve of comparable size,” commented Dr. Thubrikar in the company’s press release. “The 1- and 5-year patient outcomes are a testament to the superior design of the Optimum TAV. For the ongoing evolution of TAVI, the Optimum TAV has the durability required for younger patients. We look forward to bringing this technology to more patients and demonstrating the control offered by our new Precision 2 catheter.”

Susheel Kodali, MD, and Mathew Williams, MD, provided guidance on the development of the new catheter as medical advisors to the company. Dr. Kodali is Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center in New York, New York. Dr. Williams is Director of the Heart Valve Center at NYU Langone Health in New York.