Two transcatheter heart valves (Sapien XT and Sapien 3; Edwards Lifesciences; Irvine, CA) have been approved for an expanded indication by the US Food and Drug Administration.

Previously, these devices were only approved for patients at high or greater risk for death or surgical complications. “Traditionally, open-heart surgery has been the gold standard for aortic valve replacement in intermediate risk patients,” the FDA noted in a news release.

“About one-third of patients referred for open-heart surgery for aortic valve replacement fall into the ‘intermediate risk’ category, which his defined as having greater than 3% risk of dying within 30 days following surgery.”

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Two clinical studies were conducted to assess safety and effectiveness in patients with aortic stenosis at intermediate risk.  

In the first study, one group of patients were randomly chosen to have transcatheter aortic valve replacement using the Sapien XT valve while the other group received traditional valve replacement during open-heart surgery with a surgical tissue valve. In the second study, patients were implanted with the Sapien 3 valve.

“The two studies demonstrated a reasonable assurance of safety and effectiveness of the Sapien XT and Sapien 3 devices in intermediate risk patients,” the FDA stated.

In addition, the FDA will require the manufacturer to conduct a post-approval study for 10 years to monitor safety and effectiveness in the patients implanted with either device.


FDA approves expanded indication for 2 transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery [news release]. Silver Spring, MD: US Food and Drug Administration; August 18, 2016.