Thoratec (NSDQ:THOR) said today that it completed enrollment in a clinical trial of its HeartMate III left ventricular assist device it hopes will lead to CE Mark approval in the European Union.
The trial, which will track 50 patients, is being conducted at sites in Australia, Europe and Canada.
The Pleasanton, Calif.-based cardiac assist device company expects to have 6-month survival data available in May 2015, with a commercial launch anticipated late next year.
"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," president & CEO Keith Grossman said in prepared remarks. "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.”
Thoratec began enrolling patients in a large-scale U.S. clinical trial for the HeartMate III device in September, the same month it named Grossman as CEO after the ouster of Gary Burbach, who is expected to stay on as an advisor until early 2016. Grossman, a long-time board member, headed Thoratec from 1996 to 2006.