12.02.14
Pleasanton, Calif.-based Thoratec Corp. had completed enrollment in its HeartMate III CE mark trial. This trial enrolled a total of 50 patients at ten sites across Europe, Canada, and Australia.
“We are very pleased with the rapid completion of enrollment in the HeartMate III CE Mark study, marking a significant clinical milestone in the mechanical circulatory support industry,” said President and CEO D. Keith Grossman. “Our swift enrollment pace demonstrates the growing enthusiasm for HeartMate III across the clinical community and keeps us well on schedule to meet targeted timelines for approval of this exciting new technology.”
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. The CE mark trial will evaluate patient survival with a six-month follow up period, which will be reached in May 2015. Thoratec expects regulatory submission of CE mark data next year, with an approval and commercial launch in late 2015.
Thoratec makes device-based mechanical circulatory support therapies for cardiac applications.
“We are very pleased with the rapid completion of enrollment in the HeartMate III CE Mark study, marking a significant clinical milestone in the mechanical circulatory support industry,” said President and CEO D. Keith Grossman. “Our swift enrollment pace demonstrates the growing enthusiasm for HeartMate III across the clinical community and keeps us well on schedule to meet targeted timelines for approval of this exciting new technology.”
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. The CE mark trial will evaluate patient survival with a six-month follow up period, which will be reached in May 2015. Thoratec expects regulatory submission of CE mark data next year, with an approval and commercial launch in late 2015.
Thoratec makes device-based mechanical circulatory support therapies for cardiac applications.