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Richard N. Fogoros, M.D.

FDA Approves New Transcatheter Aortic Valve Device

By January 22, 2014

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Last week, the Food and Drug Administration approved the use of Medtronic's CoreValve, a transcatheter aortic valve implantation device (TAVI), for patients with severe aortic stenosis who are considered too sick for standard valve-replacement surgery.

FDA approval was based on results of the CoreValve Extreme Risk trial, in which inoperable patients with aortic stenosis received the CoreValve.  Their incidence of death or stroke at one year was 25.5%, which was significantly improved compared with the expected value of 40.7%.

While TAVI is a major advance in the treatment of aortic stenosis, it still carries significant risk - which is why its use is currently limited to patients who are otherwise deemed inoperable.

Read about TAVI for treating aortic stenosis here.

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