Thubrikar Aortic Valve has received approval from the Polish Authorities to conduct a clinical trial using its Optimum transcatheter aortic valve implantation (TAVI) system.

The CE Mark-enabling pilot study is structured to enrol patients with severe Aortic Stenosis and will start implanting the first five patients in early 2022.

The US-based heart valves maker has designed the Optimum TAV as a low profile, self-expanding valve, containing a nickel-titanium (nitinol) frame and bovine pericardial tissue leaflets.

To make the Optimum TAV repositionable, recapturable, and retrievable during the TAVI procedure, the company has designed a new-generation delivery catheter, Precision 2.

Also, Optimum TAV comes with a short frame, which reorients as it is deployed in the diseased valve, resulting in axial alignment of the valve.

The Precision 2 Catheter provides enhanced control and repositionability during valve deployment and axial alignment, said the company.

Thubrikar Aortic Valve founder and president, and Optimum TAV inventor Mano Thubrikar said: “We are thankful to our Engineers and Medical Advisors for this progress. 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.”

According to the company, its Optimum TAV showed more than 24 years durability in bench testing, and showed less calcification compared to surgical valves in extended animal implants.

The Optimum TAVI system is claimed to be well suited for aortic valve replacement, particularly for younger patients, due to its next-generation delivery catheter and durable valve.

The first patient implanted with Optimum TAV continues to show positive results at three years, said the company.

Furthermore, Optimum TAV was designed to mimic the natural aortic valve, and based on 30 years of research by the company’s founder, Dr. Mano Thubrikar.