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.
The majority of devices used to treat congenital cardiac lesions in the cardiac catheterization laboratory are used on an off-label basis. This article discusses the predicaments faced by the interventional cardiologist when implanting devices on an off-label basis, using procedural examples of PFO closure and endovascular stent placement. Strategies that may benefit patient and provider, as well as satisfying regulatory agencies are suggested.
Holzer
Ralf
R
The Heart Center, Nationwide Children's Hospital, Columbus, OH 43205, USA. Ralf.Holzer@NationwideChildrens.org
Hijazi
Ziyad
Z
D000293:Adolescent; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D003257:Consumer Product Safety; D003661:Decision Support Techniques; D018795:Device Approval; D005260:Female; D054092:Foramen Ovale, Patent / Q000628:therapy; D033161:Government Regulation; D006330:Heart Defects, Congenital / Q000628:therapy*; D006801:Humans; D016365:Liability, Legal; D008297:Male; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D011356:Product Labeling; D018570:Risk Assessment; D015607:Stents; D016896:Treatment Outcome