FDAnews
www.fdanews.com/articles/101598-u-s-fda-staff-thoratec-device-just-missed-goal

U.S. FDA Staff: Thoratec Device Just Missed Goal

November 29, 2007
A Thoratec Corp. study of an experimental implanted heart pump showed it narrowly missed a preset goal to gauge effectiveness, U.S. medical device reviewers said in documents released on Wednesday.
Guardian Unlimited