COLLEGE PARK, Md. (AP) — Federal health advisers say an electronic heart implant should be approved for millions of new heart-disease patients who currently aren't eligible for the device.
A Food and Drug Administration panel of cardiologists voted unanimously in favor of Boston Scientific's heart-regulating device to treat mild heart failure. Currently the device is approved for moderate to severe heart failure.
The FDA is not required to follow the panel's advice, though it often does.
A positive FDA decision would expand the market for the devices by millions of patients.
The device combines a defibrillator, which shocks the heart to correct irregular beats, with a resynchronization device to coordinate the pumping action of the heart.Copyright © 2015, Los Angeles Times