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The off‐ versus on‐label use of medical devices in interventional cardiovascular medicine: Clarifying the ambiguity between regulatory labeling and clinical decision‐making, Part 1: PCI
Author(s) -
Price Matthew J.,
Teirstein Paul S.
Publication year - 2008
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.21697
Subject(s) - medicine , food and drug administration , conventional pci , percutaneous coronary intervention , off label use , intensive care medicine , regulatory science , clinical decision making , cardiology , medical emergency , pathology , myocardial infarction
The Food and Drug Administration convened a special public meeting of the Circulatory System Devices Advisory Panel in late 2006 in response to data suggesting a small but potentially significant increased risk of stent thrombosis with drug‐eluting stents (DES). This panel concluded that “off‐label” DES use was associated with an increased risk of adverse outcomes compared with “on‐label” use. In this commentary, we will discuss the role of product labeling in clinical decision‐making during percutaneous coronary intervention, elucidate the issues that may arise from the conflation of the responsibilities of regulatory bodies and physicians, and offer a potential framework for their resolution. © 2008 Wiley‐Liss, Inc.