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.
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.
Price
Matthew J
MJ
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA. price.matthew@scrippshealth.org
Teirstein
Paul S
PS
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D003257:Consumer Product Safety; D003661:Decision Support Techniques; D018795:Device Approval; D054855:Drug-Eluting Stents; D033161:Government Regulation; D006801:Humans; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D018570:Risk Assessment; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome; D014481:United States