Thubrikar Aortic Touts Success of the Optimum TAVI System

Thubrikar Aortic Valve Inc. is sharing positive results in five additional patients implanted with the Optimum Transcatheter Aortic Valve (Optimum TAV) using the Precision 2 Delivery Catheter. Both the valve and delivery catheter performed well during the procedures, despite the patients’ anatomical challenges.
 
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. “I wish all my routine TAVR patients had the same procedural results we have achieved with the Optimum TAV and 2nd-generation delivery system,” Dr. Trebacz stated. He will present outcomes from the TAVI-1 trial of the Optimum TAVI System at the Transcatheter Cardiovascular Therapeutics (TCT) Conference next week during the “Innovations in TAVR Systems and New Clinical Updates” session (Oct. 28).
 
The Optimum TAVI System, comprised of the Optimum TAV and the Precision 2 Catheter, is a next-generation system built to address the durability crucial for a younger patient population. The Optimum TAV is billed as the only short and self-expanding valve platform.
 
“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,” Thubrikar Aortic Valve Founder/President Dr. Mano Thubrikar said. “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 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 first-in-human patient doing very well after nearly six years. The company is authorized to implant Optimum TAV in at least eight more patients in Poland, and has plans to expand the Optimum TAVI System CE Mark trial to two additional European countries.
 
Thubrikar Aortic Valve, Inc. is a privately held medical device company aiming to revolutionize aortic stenosis treatment by commercializing a transcatheter aortic valve durable enough for all patients. The Collegeville, Pa.-based company was founded by Dr. Thubrikar, a leading authority on the aortic valve.