HeartWare Receives Third Patient Allotment From FDA

HeartWare International, Inc.

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 (

). 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.