title: Beyond indications: postmarket surveillance and the importance of expanded and off-label use of transcatheter devices in structural and congenital interventions.
authors.affiliation: New York University Medical Center, NY 10016, USA. doff.mcelhinney@nyumc.org
authors.forename: Doff B
authors.initials: DB
authors.lastname: McElhinney
mesh_terms: D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D017277:Drug Approval; D004867:Equipment Design; D019317:Evidence-Based Medicine; D006330:Heart Defects, Congenital / Q000628:therapy*; D006331:Heart Diseases / Q000628:therapy*; D006801:Humans; D061214:Patient Safety; D017410:Practice Guidelines as Topic; D011356:Product Labeling / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000592:standards; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards