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

FDA advisors agreed with St. Jude Medical 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.

FDA advisors agreed with St. Jude Medical 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.

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