Thubrikar Aortic Valve Announces Clinical Success of the New Precision 2™ Delivery Catheter

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Thubrikar Aortic Valve, Inc. today announced successful results in the first two patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV™) using the new Precision 2™ Delivery Catheter. Interventional Cardiologist and TAVI-1 Study Principal Investigator, Jaroslaw Trebacz, MD, performed the procedures at the John Paul II Hospital in Krakow, Poland. “The first two implants with the 2nd-generation delivery catheter could not be easier or more effective. From the operator’s perspective, it felt like a surprisingly mature and user-friendly device. I’m truly looking forward to the next cases,” stated Dr. Trebacz.

“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.”

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The Precision 2 Catheter provides operators with unprecedented control during the TAVI procedure. Due to the innovative catheter 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 development of the new catheter.

In the 8 patients the Company 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. 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 true next-generation system built to address the durability vital for a younger patient population. The Company is continuing to enroll up to a total of 20 patients in Poland, and plans to expand the Optimum TAVI System CE Mark trial to two additional European countries.

Dr. Mano Thubrikar, the Company’s Founder and President, stated, “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.”

About Thubrikar Aortic Valve

Thubrikar Aortic Valve, Inc. is a privately held medical device company on a mission to revolutionize the treatment of Aortic Stenosis by bringing to the hands of physicians, and their patients, a transcatheter aortic valve durable enough for all patients. The Company was founded by Dr. Mano Thubrikar, a leading authority on the aortic valve. For more information, visit www.tavi.us and follow the Company on LinkedIn.

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