The Food and Drug Administration on Friday approved MRI-compatible labeling for Abbott Laboratories' Ellipse implantable cardioverter defibrillator and associated high voltage leads.
The device detects abnormally fast heart rhythms in a patient and delivers electrical pulses to restore the heart's natural rhythm. Under the new approval, past and future patients implanted with the Ellipse ICD device may receive an MRI scan, if necessary.
"When you consider the number of patients each year who rely on the life-saving treatment delivered by an ICD device, it is critical to continually innovate to provide new benefits to people battling complex arrhythmias and other cardiac conditions," said Mark Carlson, MD, CMO for Abbott's cardiac arrhythmias and heart failure division.
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