Thubrikar Aortic Valve Announces Authorization to Expand the TAVI-1 CE Mark Trial with the Precision 2 Delivery Catheter


Thubrikar Aortic Valve, Inc. today announced authorization from the Competent Authority of Poland to expand the TAVI-1 CE Mark trial of the Optimum Transcatheter Aortic Valve Implantation System™ (Optimum TAVI System™). The authorization allows for an additional 15 patients to be treated with the Optimum TAV™ using the Company’s 2nd-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, Dr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center, and Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health, provided guidance on the development of the new catheter.

The authorization 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 5 patients in the TAVI-1 trial demonstrates extraordinary valve performance. “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,” noted Dr. Mano Thubrikar, the Company’s Founder and President, and inventor of the Optimum TAV. 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 KCCQ scores.

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

“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,” commented Dr. 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.

Drs. Williams and Kodali report disclosures with Thubrikar Aortic Valve, Inc.