The U.S. Food and Drug Administration has approved Minneapolis-based Medtronic's application to expand the indications for certain pacemakers and defibrillators for patients with heart failure.
The newly approved indication allows two of Medtronic's cardiac resynchronization pacemakers and eight cardiac resynchronization defibrillators to be used in patients with atrioventricular block and moderate, mild or severe heart failure, as well as providing pacing on both sides of the heart.
Clinical trials demonstrated a 27 percent reduction in death, heart failure-related urgent care visits and an increase in left ventricular end systolic volume index, a diagnostic measure of cardiac structure and function, according to an FDA news release.
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