Thubrikar Aortic Valve, Inc. today announced successful results in an additional 5 patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV™) using the Precision 2™ Delivery Catheter. These procedures demonstrated excellent performance of both the valve and delivery catheter, despite the anatomical challenges presented by the patients.
Interventional Cardiologist and TAVI-1 CE Mark trial Principal Investigator, Dr. Jaroslaw Trebacz, conducted the procedures at the John Paul II Hospital in Krakow, Poland. Dr. Trebacz remarked, "I wish all my routine TAVR patients had the same procedural results we have achieved with the Optimum TAV and 2nd-generation delivery system.” He will present outcomes from the TAVI-1 trial of the Optimum TAVI System™ at the world-leading Transcatheter Cardiovascular Therapeutics (TCT) Conference in the “Innovations in TAVR Systems and New Clinical Updates” session on October 28.
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 crucial for a younger patient population. The Optimum TAV remains unrivaled as the only short and self-expanding valve platform.
Dr. Mano Thubrikar, the Company’s Founder and President, emphasized, “Two-year follow-up data from the TAVI-1 trial confirm the pressure gradient and effective orifice area of the Optimum TAV continue to be superior to that published on any other TAV of similar size. With the increasing prevalence of Redo-TAVR, the durability of current TAVs has become of critical concern. The Optimum TAV is engineered to excel in durability, as evidenced by its outstanding preclinical durability and clinical results, likely delaying redo procedures by several years.”
To date, the Optimum TAV has been successfully implanted in 13 patients, with the global FIH patient doing very well after nearly 6 years. The Company has authorization to implant at least 8 more patients in Poland, and has plans to expand the Optimum TAVI System CE Mark trial to two additional European countries.
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.
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Contacts
Thubrikar Aortic Valve
Samir Wadke, Vice President of Business Development
Samir.Wadke@tavi.us
