Thubrikar Aortic Valve Announces Clinical Success of the New Precision 2™ Delivery Catheter
06 Mayo 2024 - 3:58PM
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240506373445/en/
Thubrikar Aortic Valve Samir Wadke, Vice President of Business
Development Samir.Wadke@tavi.us