Population
Pediatric cardiac populations undergoing interventional catheterization procedures
Design
Review
Authors
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Common off-label pediatric device use warrants regulatory scrutiny; leaves open optimal trial designs for dedicated approvals.
Highlights the critical need to enhance cardiac device review and approval processes to include pediatric applications due to the high prevalence of off-label device use in pediatric interventional cardiology.
Jamie S. Sutherell (2011) studied this question.
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