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

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.

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  • 1The Heart Center, Nationwide Children's Hospital, Columbus, OH 43205, USA.


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.

(c) 2008 Wiley-Liss, Inc.

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