This article was originally published in The Gray Sheet
Executive SummaryThoratec will launch the HeartMate II continuous-flow left-ventricular assist device in Europe by the end of the year following receipt of a CE mark Nov. 7. The approval was based on data from 20 patients enrolled in a Phase I U.S. trial and a European trial. A 200-patient Phase II study to support U.S. approval of the next-generation device has enrolled 102 patients so far - 52 in the bridge-to-transplant arm and 50 in the destination-therapy arm. A total of 143 patients have been implanted with HeartMate II to date, according to the firm...
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