Thubrikar Marks Success of First Optimum TAV Implants Using its Precision 2 Catheter

Thubrikar Aortic Valve Inc. is extolling successful results in the first two implants with its Optimum Transcatheter Aortic Valve (Optimum TAV) using the new Precision 2 Delivery Catheter.
 
The Precision 2 Catheter provides operators with improved control during a transcatheter aortic valve implantation (TAVI) procedure. Due to the catheter’s design and the Optimum TAV’s short frame, the valve reorients as it is deployed resulting in automatic axial alignment with the native valve. Positioning the valve requires no complex maneuvers, and it is completely visible under fluoroscopy without the need for radiopaque markers. The Precision 2 Catheter also allows the Optimum TAV to be repositioned and recaptured for retrieval. The company’s Medical Advisors, Dr. Susheel Kodali, director of the Structural Heart & Valve Center at New York-Presbyterian Hospital/Columbia University Medical Center, and Dr. Mathew Williams, director of the Heart Valve Center at NYU Langone Health, provided guidance on the catheter’s development.

“The first two implants with the second-generation delivery catheter could not be easier or more effective,” said interventional cardiologist and TAVI-1 study principal investigator Jaroslaw Trebacz, M.D., who performed the procedures at the John Paul II Hospital in Krakow, Poland. “From the operator’s perspective, it felt like a surprisingly mature and user-friendly device. I’m truly looking forward to the next cases.” 
 
In the eight patients Thubrikar has implanted with the Optimum TAV, valve performance has been outstanding: Post-implant mean pressure gradients and effective orifice areas are superior to those published on any transcatheter aortic valve of comparable size, according to the company. The Optimum TAV demonstrates pre-clinical durability surpassing that of even surgical bioprosthetic valves, which are thought to be more durable than transcatheter valves. It has a self-expanding design that is less than half the height of commercial self-expanding platforms, allowing full access for future coronary interventions. The Optimum TAV may also be used to treat patients with a failed surgical or transcatheter valve.
 
The Optimum TAVI System, comprised of the Optimum TAV and the Precision 2 Catheter, is a next-generation system built to address the durability vital for a younger patient population. The company is continuing to enroll up to 20 total patients in Poland, and plans to expand the Optimum TAVI System CE Mark trial to two additional European countries.
 
“The Optimum TAVI System offers patients a more durable transcatheter valve and physicians a more user-friendly delivery catheter. It will be the system of choice. We look forward to treating more patients soon,” Thubrikar Founder/President Dr. Mano Thubrikar stated.
 
Thubrikar Aortic Valve is a privately held medical device company aiming to revolutionize aortic stenosis treatment by developing a transcatheter aortic valve durable enough for all patients. The firm is based in Collegeville, Pa.