The use of devices to treat disorders and diseases affecting pediatric patients has increased significantly since the 1980s, particularly in the field of pediatric cardiology where interventional procedures have become viable alternatives to open heart surgery for many conditions 1, 2. Yet as the treatment of congenital heart disease (CHD) with cardiac catheterization and device placement has evolved, there remains a lack of devices on the market that are designed for, studied in, and specifically labeled for pediatric patients and evidence-based data to guide decision making in treating these patients remains scarce. Treatment strategies instead are derived largely from expert opinion-which may not be consistent across locales or widely accessible-and off-label use is not uncommon 3.
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