MASSDEVICE ON CALL — Germany-based medical device company Transcatheter Technologies GmbH is making a bold stride into the transcatheter aortic valve implantation space, announcing 1st-in-man implantation of a device it says it intends to be the "the world’s best repositionable heart valve."
The young company faces some stiff competition in the repositionable TAVI arena, with medtech giants Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) also vying to get their next-generation repositionable TAVI systems on the market.
"A major limitation of existing transcatheter aortic heart valves is that they cannot be repositioned once implanted," Transcatheter Technologies CEO Dr. Wolfgang Goetz said in prepared remarks. "Trinity, however, is designed to solve this difficult problem."
"With Trinity, once our valve is initially placed, a cardiologist can fully evaluate the valve’s function to determine whether it needs to be repositioned, retrieved, or kept in the same position," he added. "Equally important, Trinity provides for controlled positioning by allowing a cardiologist to slowly open the valve stent, thus improving the likelihood of a first-attempt correct placement."
Minnesota medical device titan Medtronic earlier this month launched a 60-patient clinical trial of its new CoreValve Evolut R repositionable heart valve, consisting of the CoreValve Evolut R device and Medtronic’s EnVeo R "recapturable" delivery system. St. Jude in November 2012 won CE Mark approval in the European Union for its repositionable and retrievable Portico TAVI system.
Transcatheter Technologies plans this week to release new data from its 1st-in-man studies during the Transcatheter Cardiovascular Therapeutics symposium in San Francisco.
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