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TRANSCATHETER OCCLUSION DEVICE NON-RANDOMIZED TRIALS APPROPRIATE FOR PDA, ASD INDICATIONS; RANDOMIZATION IS FEASIBLE FOR PFO STUDIES, FDA ADVISORY PANEL SAYS

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of transcatheter occlusion devices intended for treatment of patent ductus arteriosus (PDA) and atrial septal defect (ASD) should be able to conduct non-randomized trials to support FDA premarket approval, members of FDA's Circulatory System Devices Panel agreed at an Oct. 24 meeting in Gaithersburg, Maryland.
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