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. © 2008 Wiley‐Liss, Inc.