Thubrikar Aortic Valve, Inc. (the “Company”), a privately held medical device company developing a next-generation transcatheter aortic valve implantation (TAVI) system, announced today that its Optimum TAV has surpassed 200 million cycles in an ongoing durability test - which simulates over 5 years in humans and meets the requirement set by the International Organization for Standardization (ISO) - in a third party GLP study.
“We are happy to report this most significant pre-clinical milestone, which demonstrates excellent hemodynamic and durability performance by Optimum TAV. Durability tests stifle many heart valve developers, who are then confronted with having to redesign the device before repeating the 6-month test,” stated Dr. Mano Thubrikar, the Company’s Founder and President. “We designed Optimum TAV to outlast all other currently known transcatheter valves and look forward to implanting our device in humans in early 2014.” The Company previously demonstrated feasibility of its Optimum TAV and delivery catheters in 8 acute and chronic sheep. The Company has filed patents for its Optimum TAV and catheters, and has accomplished all of these milestones within $1 Million USD.