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Editor's Note
June 2015

High-Risk Medical DevicesWhy Do We Not Better Understand Effectiveness and Safety?

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Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Intern Med. 2015;175(6):939-940. doi:10.1001/jamainternmed.2015.0578

The intra-aortic balloon pump (IABP), a mechanical device designed to increase both myocardial perfusion and cardiac output, was pioneered in the 1960s to treat patients in cardiogenic shock. An innovation at the time, the device was made available for use prior to passage of the 1976 Medical Device Amendments, which gave the US Food and Drug Administration (FDA) authority to require evidence of effectiveness and safety for high-risk medical devices before granting market clearance. It is likely that no clinical data were submitted for FDA review prior to market clearance of the IABP. More than 70 000 IABPs are inserted annually in the United States for a broad array of indications including acute coronary syndromes, cardiac surgery, complications of heart failure, and cardiogenic shock. Some estimate that half of all patients hospitalized for acute myocardial infarction (AMI) complicated by cardiogenic shock receive IABP therapy.

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