The off-versus on-label use of medical devices in interventional cardiovascular medicine?: Clarifying the ambiguity between regulatory labeling and clinical decision making, part III: Structural heart disease interventions

Catheterization and Cardiovascular Interventions

Volumn 72, Issue 6, 2008, Pages 848-852

  Holzer, Ralf ^a   Hijazi, Ziyad ^b  

^a NATIONWIDE CHILDREN S HOSPITAL   (United States)

^b RUSH UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Medical devices; Off label use; Pediatric interventions; PEDS

Indexed keywords

ANTICOAGULANT AGENT; ANTITHROMBOCYTIC AGENT;

ARTICLE; CLINICAL DECISION MAKING; CONGENITAL HEART DISEASE; CORONARY STENT; DRUG ELUTING STENT; FALLOT TETRALOGY; HEART ASSIST DEVICE; HUMAN; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; MEDICAL LIABILITY; PARADOXICAL EMBOLISM; PATENT DUCTUS ARTERIOSUS; PATENT FORAMEN OVALE; STENT; ADOLESCENT; CONGENITAL HEART MALFORMATION; DECISION SUPPORT SYSTEM; FEMALE; GOVERNMENT REGULATION; HEART CATHETERIZATION; INSTRUMENTATION; LEGAL ASPECT; LEGAL LIABILITY; MALE; PACKAGING; PATIENT SELECTION; PRACTICE GUIDELINE; RISK ASSESSMENT; SAFETY; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

ADOLESCENT; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CONSUMER PRODUCT SAFETY; DECISION SUPPORT TECHNIQUES; DEVICE APPROVAL; FEMALE; FORAMEN OVALE, PATENT; GOVERNMENT REGULATION; HEART CATHETERIZATION; HEART DEFECTS, CONGENITAL; HUMANS; LIABILITY, LEGAL; MALE; PATIENT SELECTION; PRACTICE GUIDELINES AS TOPIC; PRODUCT LABELING; RISK ASSESSMENT; STENTS; TREATMENT OUTCOME;

EID: 58849162345     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.21708     Document Type: Article

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