FDA OKs CoreValve TAVI Device

Submitted by: Erica CurcioGold Contributor

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Author(s): Todd Neale

The FDA approved the CoreValve TAVI device for use in the US. The approval was originally expected to occur in April 2014, but the panel decided that an independent review of data from the clinical study of extreme-risk patients in the CoreValve US Pivotal Trial was not needed at this time.

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