Posts Tagged ‘ASD occlusion devices’

July 2nd, 2012

Eroding Confidence in ASD Occlusion Devices

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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 […]