Thubrikar Wins Authorization to Expand the TAVI-1 CE Mark Trial in Poland

The Competent Authority of Poland has granted Thubrikar Aortic Valve Inc. permission 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 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 new catheter’s development.
 
The authorization also allows for one additional clinical study 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. “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,” Thubrikar Founder/President Dr. Mano Thubrikar, inventor of the Optimum TAV, noted. “The patients have shown remarkable clinical improvement at one 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 five years.
 
“The one- and five-year patient outcomes are a testament to the 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,” Thubrikar stated.
 
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.
 
Thubrikar Aortic Valve Inc. is a privately-held medical device company developing an aortic stenosis treatment via a transcatheter aortic valve durable enough for all patients. The company is based in Collegeville, Pa.