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St. Jude Shoots For 2016 With PFO Closure Device For Stroke

Slam-dunk data supporting patent foramen ovale closure to prevent stroke has been elusive, but St. Jude now says discussions with FDA suggest that its device could be approved in 2016 following a panel meeting.

St. Jude Medical Inc. is "optimistic" that it will gain FDA approval for a patent foramen ovale closure device to prevent stroke in 2016, the firm's CEO Daniel Starks said on a July 22 earnings call.

The firm's Amplatzer PFO occlude was studied in the 980-patient RESPECT trial in which the device missed its primary intention-to-treat endpoint, but showed advantages compared to medication alone in preventing...

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