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Advisors Provide Lukewarm Endorsement Of St. Jude's PFO Occluder For Stroke

This article was originally published in The Gray Sheet

Executive Summary

FDA's Circulatory System Devices Panel said that St. Jude's Amplatzer PFO closure device has benefits that outweigh risks to prevent recurrent stroke in a select group of patients on an 11-5 vote, despite having missed its primary endpoint in the pivotal RESPECT trial.

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