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

Catheter Cardiovasc Interv. 2008 Nov 15;72(6):848-52. doi: 10.1002/ccd.21708.

Abstract

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.

MeSH terms

  • Adolescent
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / legislation & jurisprudence
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Consumer Product Safety
  • Decision Support Techniques*
  • Device Approval*
  • Female
  • Foramen Ovale, Patent / therapy
  • Government Regulation*
  • Heart Defects, Congenital / therapy*
  • Humans
  • Liability, Legal
  • Male
  • Patient Selection*
  • Practice Guidelines as Topic
  • Product Labeling*
  • Risk Assessment
  • Stents*
  • Treatment Outcome