Why the study?
What is the prevalence of off-label medical device use in pediatric interventional cardiology?
Population
473 pediatric patients undergoing 595 transcatheter interventions at a single US institution between July…
Comparison
Transcatheter interventions using medical devices vs Manufacturer's labeled indications for each device
Design
Cohort
Authors
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Prevalent off-label device use in pediatric interventions warrants clinical caution; leaves open need for dedicated safety trials and approvals.
What is the prevalence of off-label medical device use in pediatric interventional cardiology?
Off-label use of medical devices is highly prevalent in pediatric interventional cardiology, highlighting the need for pediatric-specific device approvals.
Sutherell et al. (2010) studied this question.
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