US-based medical device company Thubrikar Aortic Valve has received approval from the Competent Authority of Poland to extend the TAVI-1 CE Mark trial for the Optimum Transcatheter Aortic Valve Implantation System (Optimum TAVI System).

The authorisation permits the treatment of an additional 15 patients using the Optimum TAV with the company’s second-generation delivery catheter, the Precision 2 Catheter. It also permits the use of an additional clinical site in Poland.

The TAVI-1 CE Mark trial will now see patient implants at the Specialty Hospital Jana Pawla II in Krakow as well as the University Clinical Hospital Jana Mikulicza-Radeckiego located in Wroclaw.

Thubrikar Aortic Valve said that the Precision 2 Catheter has been designed for enhanced operator control. This enables the repositioning and potential retrieval of the Optimum TAV during the TAVI procedure.

The catheter design facilitates the automatic axial alignment of the Optimum TAV’s short frame as it is deployed in the diseased valve, said the company.

Data from the previous five patients in the TAVI-1 CE Mark trial showed extraordinary valve performance, claimed the company.

Thubrikar Aortic Valve founder and president and Optimum TAV inventor Mano Thubrikar said: “We have completed 1-year follow-up on 5 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.”

According to Thubrikar Aortic Valve, the patients have demonstrated significant clinical improvement at the one-year mark, experiencing freedom from all-cause mortality, stroke, and hospitalisation related to the procedure or valve.

Additionally, there have been observed increases in their KCCQ scores, said the company.

In 2018, Labcor, the licencee of the company, conducted the first implantation of the Optimum TAV in Brazil and outstanding haemodynamic performance of the valve and sustained clinical efficacy has been affirmed over a span of five years.

Thubrikar said: “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.”