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

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.

FDA advisors agreed with St. Jude Medical Inc. that its Amplatzer patent foreman ovale occluder has benefits for select patients that outweigh the risks for recurrent strokes, at a Circulatory System Devices Panel meeting. However, many of the advisors at the May 24 meeting in Gaithersburg, Md., also pointed to the need for continuing medication with anti-clotting agents for patients implanted with the device. (See Also see "St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel" - Medtech Insight, 12 April, 2016..)

The panel voted 11-5 that benefits outweigh the risks with use of Amplatzer, and had a closer, 9-7 vote in support of the device being effective. The committee voted 15-1...

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