FDA Expands Approval For Valve-in-Valve Replacement

On March 30, the U.S. Food and Drug Administration (FDA) expanded the approval of Medtronic’s CoreValve System to include “valve-in-valve” replacement for patients in need of a second tissue aortic valve replacement after undergoing a previous one. This expanded approval is for patients who are at high or extreme- risk of complications during traditional open-heart surgery.

The CoreValve System—made from the heart tissue of a pig—uses a catheter delivery system to replace the failed tissue aortic valve with an artificial valve. The major risks associated with this transcatheter aortic valve replacement technology include death, stroke, heart attack, bleeding, and the need for a permanent pacemaker. The system was first approved as a treatment for patients with a narrowed aortic valve due to calcium build-up around the aortic stenosis.

Read more in the FDA’s announcement.


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