Thubrikar Aortic Valve has received authorisation from the Competent Authority of Poland to expand the TAVI-1 CE mark trial of the Optimum transcatheter aortic valve implantation (TAVI) system.
The authorisation allows for an additional 15 patients to be treated with the Optimum TAV using the Company’s second-generation delivery catheter, the Precision 2 catheter.
The Precision 2 catheter is engineered to provide operators with significant control. It allows the Optimum TAV to be repositioned and recaptured for retrieval, if necessary, during the TAVI procedure. Due to the innovative catheter design, the Optimum TAV’s short frame reorients as it is deployed in the diseased valve which results in automatic axial alignment of the valve.
The Company’s Medical Advisors, Susheel Kodali (New York-Presbyterian/Columbia University Medical Center, New York, USA) and Mathew Williams (NYU Langone Health, New York, USA) provided guidance on the development of the new catheter.
The authorisation also allows for an additional clinical site in Poland. The trial will now include patient implants at both the Specialty Hospital Jana Pawla II in Krakow, and the University Clinical Hospital Jana Mikulicza-Radeckiego in Wroclaw.
Data from the prior five patients in the TAVI-1 trial demonstrates extraordinary valve performance, the company says in a press release.
“We have completed one-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,” noted Mano Thubrikar, the company’s founder and president, and inventor of the Optimum TAV. The patients have shown remarkable clinical improvement at one year, including freedom from: all-cause mortality, stroke, and hospitalisation for procedure- or valve-related causes, as well as increases in their Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.
The company’s licensee, Labcor, implanted the first patient with the Optimum TAV in Brazil in 2018. Excellent valve haemodynamic performance and long-term clinical efficacy have now been demonstrated at five years.
“The one- and five-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,” commented Thubrikar.
At less than half the height of commercial self-expanding platforms, the Optimum TAV allows full coronary access. It mimics the optimal geometry and leaflet dynamics of the natural aortic valve and has no suture holes in the flexion zone.
