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

Catheterization and Cardiovascular Interventions

Volumn 72, Issue 4, 2008, Pages 500-504

  Price, Matthew J ^a,b   Teirstein, Paul S ^a  

^a SCRIPPS CLINIC   (United States)

^b NONE   (United States)

Author keywords

Drug eluting stent; Off label; On label; Percutaneous coronary intervention (PCI); Regulatory

Indexed keywords

HEPARIN; PACLITAXEL; RAPAMYCIN; ZOTAROLIMUS;

ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL DECISION MAKING; CLINICAL TRIAL; CORONARY ARTERY BLOOD FLOW; DISEASE SEVERITY; DOCTOR PATIENT RELATION; DRUG ELUTING STENT; EQUIPMENT DESIGN; FOOD AND DRUG ADMINISTRATION; HEART CATHETERIZATION; HEART INFARCTION; HEART MUSCLE REVASCULARIZATION; HUMAN; IN-STENT RESTENOSIS; MEDICAL CARE; MEDICAL INSTRUMENTATION; MEDICAL PRACTICE; PATIENT SAFETY; PERCUTANEOUS CORONARY INTERVENTION; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; QUALITY CONTROL; SAPHENOUS VEIN GRAFT; STANDARDIZATION; THROMBOSIS; TREATMENT INDICATION; DECISION SUPPORT SYSTEM; GOVERNMENT REGULATION; INSTRUMENTATION; LEGAL ASPECT; PATIENT SELECTION; RISK ASSESSMENT; SAFETY; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME; UNITED STATES;

ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CONSUMER PRODUCT SAFETY; DECISION SUPPORT TECHNIQUES; DEVICE APPROVAL; DRUG-ELUTING STENTS; GOVERNMENT REGULATION; HUMANS; PATIENT SELECTION; PRACTICE GUIDELINES AS TOPIC; RISK ASSESSMENT; THROMBOSIS; TREATMENT OUTCOME; UNITED STATES;

EID: 58149237259     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.21697     Document Type: Article

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