Defect Closure: Umbrella Devices
Although catheter-delivered devices to close intracardiac defects have been successfully deployed in humans for 25 years, their use has only become widespread during the past 2–3 years. While several devices are used routinely at this writing in Europe and elsewhere, no device has yet been approved by the U.S. Food and Drug Administration. Several factors have contributed to this delay; the combination of rare diseases, parents’ and physicians’. reluctance to submit children to randomized trials, a successful, albeit highly invasive therapeutic alternative (i.e. open heart surgery), safety and efficiency criteria for FDA approval based primarily on common adult diseases. Nonetheless, it seems clear that intracardiac occlusion devices are now necessary and vital tools in the management of simple and complex congenital heart disease.
KeywordsSeptal Defect Atrial Septal Defect Ventricular Septal Defect Device Closure Atrial Septum
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