More than 160,000 implantable cardioverter–defibrillators(ICDs) are implanted annually in the United States to preventsudden death from cardiac causes in high-risk patients. Recently,concerns have been raised about the premarket testing of theselife-saving devices.1 At issue is how new ICD technologies shouldbe evaluated before they are approved by the Food and Drug Administration(FDA) for general use. ICD manufacturers strive to develop devicesthat are smaller, easier to implant, and more attractive topatients, but they are reluctant to subject these innovationsto premarket clinical testing because such trials are costlyand may delay the introduction of . . . [Full Text of this Article]
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Dr. Hauser is a cardiologist and Dr. Almquist a clinical cardiac electrophysiologist at the Minneapolis Heart Institute, Minneapolis.
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