FDA panel asks for more data on St Jude's Amplatzer
This article was originally published in Clinica
A US FDA panel has asked St Jude Medical to re-analyse existing data for its Amplatzer septal occluder after the device was linked with a serious but very rare complication. Although the decision is an inconvenience for St Jude, it could have been worse: the panel agreed that ongoing post-approval studies should remain unchanged. But the panellists did suggest a new case-controlled post-market study to "augment" the ongoing post-market surveillance.
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