Thoratec Files Application to Market HeartMate II in EU
Thoratec has filed for approval to CE Mark its HeartMate II LVAS (left ventricular assist system), the approval of which would allow the commercial launch of the device in Europe.
The regulatory application for European approval is based on data from the first 20 patients that were implanted in the company's Phase I U.S. trial and in a European study. These patients accounted for nearly 5,200 days of cumulative support and were each supported from three to 490 days. The company said it hopes to receive the authority to CE Mark the device this year.
The HeartMate II is a next generation heart assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure. Last month Thoratec received approval to begin a Phase II pivotal trial for the device in the U.S., and last week said that the first patients have been enrolled in both the destination therapy and bridge-to-transplantation arms of that trial.