HeartWare International, Inc. HTWR today announced that the U.S. Food and Drug Administration (FDA) has approved an IDE Supplement that allows HeartWare to enroll a third allotment, of 94 additional patients, in its "ADVANCE" bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).
The FDA granted two prior allotments of 54 patients each in April and September 2010, and the final patient from the second cohort was implanted earlier this month.
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