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St. Jude Halts Portico TAVR Implants Based On IDE Study Imaging Data

The firm says it is temporarily halting implants of its transcatheter aortic health valve replacement worldwide while it reviews CT data showing reduced valve leaflet mobility in some patients treated as part of St. Jude’s U.S. pivotal trial.

St. Jude Medical Inc. confirms that it has temporarily halted all new implants of its Portico transcatheter aortic heart valve replacement based on imaging data showing reduced mobility in the valve leaflets for some patients enrolled in the firm’s U.S. investigational device exemption study.

The worldwide “pause” in implants will give the company “time to evaluate recent cases of reduced valve leaflet mobility that...

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