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

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.