HeartMate III in trials for Heart Failure-Thoratec
Thoratec Corporation has announced completion of enrollment in the HeartMate III CE Mark trial for patients with Heart Failure. HeartMate III is a centrifugal-flow chronic left ventricular assist system utilizing a fully magnetically levitated technology foundation designed to lower adverse event rates while also enhancing the ease of surgical placement through a compact size.
This trial enrolled a total of 50 patients at ten sites across Europe, Canada, and Australia. The CE Mark trial will evaluate patient survival with a six-month follow up period, which will be reached in May 2015. Thoratec continues to expect regulatory submission of CE Mark data next year, with an approval and commercial launch in late 2015.
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