Thubrikar’s Optimum TAVI Device Will Be Studied to Gain CE Mark Approval

December 17, 2021—Thubrikar Aortic Valve, Inc. announced that it received approval from a Competent Authority in Poland to conduct initial patient implantations with its Optimum transcatheter aortic valve implantation (TAVI) system. The company-sponsored CE Mark-enabling pilot study of the device in patients with severe aortic stenosis will begin enrollment and treatment of the first five patients in early 2022.

According to the company, the Optimum transcatheter aortic valve (TAV) is a self-expanding device with a short profile to facilitate coronary access. The company has designed a second-generation delivery catheter, the Precision 2, that allows the Optimum TAV to be repositionable, recapturable, and retrievable during the TAVI procedure.

Optimum TAV’s short frame reorients as it is deployed in the diseased valve, which results in axial alignment of the valve. The Precision 2 catheter, with its repositionability, provides controlled valve deployment and axial alignment. Additionally, the Optimum TAV demonstrated the equivalent of more than 24 years of durability in bench testing and showed less calcification than even surgical valves in extended animal implants.

The company noted that with the next-generation delivery catheter and enhanced valve durability, the Optimum TAVI system is particularly suitable for younger patients. The first patient implanted with Optimum TAV continues to do well at 3 years.

Susheel Kodali, MD, and Mathew Williams, MD, have served as advisors for the company and have contributed to the development of the delivery catheter. They will continue to support the company in its clinical trials. 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, New York.

Mano Thubrikar, PhD, is the inventor of the Optimum TAV. He is the Founder and President of Thubrikar Aortic Valve, Inc., which is based in Norristown, Pennsylvania.

“We are thankful to our engineers and medical advisors for this progress,” commented Dr. Thubrikar in the company’s announcement. “Durability remains the key issue in TAVI—younger patients still require open heart surgery because no approved TAVs have demonstrated the durability of surgical valves. We designed the Optimum TAV after the natural aortic valve because we discovered that it has the optimal geometry for efficient performance and durability. We also ensured that Optimum TAV’s leaflets do not contain suture holes. As a result, Optimum TAV has unparalleled durability and will greatly benefit patients.”