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News From the Food and Drug Administration
October 4, 2016

Avoiding Open-Heart Surgery

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;316(13):1350. doi:10.1001/jama.2016.13788

An expanded indication approved for 2 transcatheter heart valves means more patients with aortic valve stenosis may be able to avoid invasive open-heart surgery to replace their diseased valve.

The Sapien XT and Sapien 3 transcatheter heart valves can now be used in intermediate-risk patients rather than only in patients with aortic stenosis who are at high risk of dying or developing complications during valve replacement surgery (http://bit.ly/2b49uXI).