The Food and Drug Administration (FDA) has approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves (Edwards Lifesciences) for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery.

Both the Sapien XT and Sapien 3 are catheter-based artificial aortic heart valves and contain accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. Sapien XT and Sapien 3 transcatheter heart valves are already indicated for patients at high or greater risk for death or complications during surgery. Intermediate risk is defined as having >3% risk of dying within 30 days following surgery.  

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The safety and efficacy of the Sapien XT valve was evaluated in a clinical study of aortic stenosis patients at intermediate risk for surgical complications. They were randomized to either transcatheter aortic valve replacement procedure using the Sapien XT valve (n=1,011) or a traditional aortic valve replacement during open-heart surgery using a surgical tissue valve (n=1,021). Another study evaluated intermediate risk patients that were implanted with the Sapien 3 valve (n=1,078), and their outcomes were compared to a surgical control group (n=1,021) from the first study. 

Both studies showed a reasonable assurance of safety and efficacy of the Sapien XT and Sapien 3 devices in intermediate risk patients. 

Patients who cannot tolerate blood thinners or those who are being treated for a bacterial or other infection are contraindicated from use of these devices. The FDA is requiring the manufacturer to conduct a post-approval study to monitor safety and efficacy for 10 years in patients who were treated with either device in the two studies.

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