FDA Approvals - FDA approves IDE Supplement for third patient allotment in HeartWare
FDA approves IDE Supplement for third patient allotment in HeartWare Ventricular Assist System ADVANCE trial
HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration has approved an IDE Supplement that allows HeartWare to enroll a third allotment, of 94 additional patients, in its "ADVANCE" bridge-to-transplant clinical ...