July 2nd, 2012
Eroding Confidence in ASD Occlusion Devices
Richard A. Lange, MD, MBA and L. David Hillis, MD
The FDA has identified more than 100 cases of cardiac erosion following atrial septal defect occlusion (ASO) device implantation. All were associated with implantation of the AMPLATZER (AGA Medical/St. Jude Medical) or related cribriform ASO devices; none have been reported thus far with the GORE HELEX (Gore Medical) ASO device. Although the estimated occurrence of cardiac erosion […]
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