Using the MADIT II criteria for implantable cardioverter defibrillators-what is the role of the Food and Drug Administration approval?

The results of the MADIT II study have generated a great deal of controversy in the world of electrophysiology. Much of the controversy appears related to the sheer numbers of potential Implantable Cardioverter Defibrillator (ICD) implants and their potential cost to the healthcare system. Two federal regulatory agencies, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have been highly visible in discussions. The FDA approved the MADIT II indications for Guidant ICDs, while CMS covered a limited subset of the patients studied. This review explores some the issues surrounding the trial and the key participants in this discussion with emphasis on the role of the Food and Drug Administration (FDA) and how regulatory decisions may impact on clinical practice.