FDA expands approved use of Sapien artificial heart valve

by FDA on October 19, 2012

in FDA Alerts

The U.S. Food and Drug Administration today expanded the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.

This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.

View Full Details Of Original FDA Press Release Here.

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