Medtronic wins expanded FDA OK for artificial heart valve

The FDA has granted Medtronic expanded approval for its CoreValve transcatheter aortic valve replacement system, allowing its use in severe aortic stenosis patients who are at high mortality risk if they undergo traditional open-heart procedures. The device, which was approved without going through an expert panel review, was previously approved for use in patients at extreme risk of death from surgery.

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Star Tribune (Minneapolis-St. Paul, Minn.) · CardiovascularBusiness.com

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