COLLEGEVILLE, PA — Thubrikar Aortic Valve, Inc. recently celebrated the successful implantation of the Optimum Transcatheter Aortic Valve (Optimum TAV™) in two patients, utilizing the innovative Precision 2™ Delivery Catheter. The procedures, which were performed by Dr. Jaroslaw Trebacz at John Paul II Hospital in Krakow, Poland, mark a milestone in the quest for better solutions for patients suffering from heart valve diseases.
Dr. Trebacz, the TAVI-1 Study Principal Investigator, praised the second-generation delivery catheter for its ease of use and effectiveness. “The first two implants with the 2nd-generation delivery catheter could not be easier or more effective,” he remarked, highlighting the device’s maturity and user-friendliness. This positive feedback underscores the potential of the Optimum TAVI System to revolutionize transcatheter aortic valve implantations (TAVI).
The Precision 2 Catheter is designed to offer operators unmatched control during the TAVI procedure, a minimally invasive alternative to open-heart surgery traditionally used for valve replacement. Its innovative design ensures automatic axial alignment with the native valve as the Optimum TAV is deployed, simplifying the positioning process and offering full visibility under fluoroscopy without the need for radiopaque markers. Additionally, the device can be repositioned and recaptured for retrieval if necessary.
With the involvement of esteemed Medical Advisors, Dr. Susheel Kodali from New York-Presbyterian Hospital/Columbia University Medical Center, and Dr. Mathew Williams from NYU Langone Health, the development of the new catheter reflects a collaborative effort to enhance procedural outcomes and patient care.
The performance of the Optimum TAV has been exemplary in all eight patients implanted so far, boasting post-implant mean pressure gradients and effective orifice areas that surpass those of any transcatheter aortic valve of comparable size currently on the market. It also demonstrates pre-clinical durability exceeding that of surgical bioprosthetic valves, typically considered more durable than transcatheter options. Its self-expanding design, less than half the height of other self-expanding platforms, facilitates full access for future coronary interventions.
Targeting a younger patient demographic concerned with the longevity of heart valve replacements, the Optimum TAVI System represents a next-generation solution addressing the critical need for more durable transcatheter valves. Thubrikar Aortic Valve, Inc. plans to expand its CE Mark trial for the Optimum TAVI System to include up to 20 patients in Poland and extend the study to two additional European countries.
Dr. Mano Thubrikar, Founder and President of Thubrikar Aortic Valve, Inc., expressed optimism about the system’s potential impact, stating, “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.” This innovation not only paves the way for enhanced quality of life for patients but also sets a new benchmark in heart valve replacement technology.
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