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Medtronic CoreValve Meets Targets In Extreme-Risk Group; Panel Will Not Be Needed, FDA Says

The firm now expects to gain approval for the extreme-risk indication of its transcatheter aortic heart valve months earlier than earlier predicted following well-received pivotal trial data reported last week at the Transcatheter Cardiovascular Therapeutics meeting.

The first report from Medtronic PLC’s U.S. pivotal study for its CoreValve transcatheter aortic valve was positive, and the firm now says that FDA will likely complete its initial PMA review for the device earlier than expected.

CoreValve lessened the risk of death and major stroke while reducing paravalvular leak, compared to an historical control, in extremely ill patients unsuitable for surgery in the “extreme risk” cohort...

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