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Perspectives
U.S. FDA Approved MADIT II Indication for the Implantable Cardioverter-Defibrillator
September 2002
Recently, the U.S. FDA approved MADIT II indications for the implantable cardioverter-defibrillator. Specifically, they find that it is an acceptable indication for implanting these devices in patients who have experienced myocardial infarction and who have severe left ventricular dysfunction (an ejection fraction of less than or equal to 30%). Importantly, the patient s do not need to have an electrophysiology study and do not need to have an arrhythmia as a prerequisite for this prophylactic indication. At the present, it is unclear when Medicare will approve this indication for reimbursement. Stay tuned as this situation evolves.