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St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel

St. Jude won a May panel date for its Amplatzer patent foreman ovale occluder PMA, seeking approval to prevent recurrent stroke. It's been a challenging path to this point after the firm's pivotal RESPECT trial did not meet its primary endpoint in 2012.

St. Jude Medical Inc. has finally secured an FDA advisory panel date for its Amplatzer patent foreman ovale occluder. The firm's PMA for the implant, intended to prevent recurrent stroke, will go before the agency's Circulatory System Devices panel May 24.

It has been a challenging path so far for the PFO closure device. St. Jude's 980-patient pivotal RESPECT trial missed its primary intent-to-treat endpoint in data presented in 2012, an...

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