Learning from Our Mistakes? Testing New ICD Technology

Abstract

More than 160,000 implantable cardioverter–defibrillators (ICDs) are implanted annually in the United States to prevent sudden death from cardiac causes in high-risk patients. Recently, concerns have been raised about the premarket testing of these life-saving devices.1 At issue is how new ICD technologies should be evaluated before they are approved by the Food and Drug Administration (FDA) for general use. ICD manufacturers strive to develop devices that are smaller, easier to implant, and more attractive to patients, but they are reluctant to subject these innovations to premarket clinical testing because such trials are costly and may delay the introduction of . . .