The U.S. Food and Drug Administration (FDA) on June 17 approved Edward Lifesciences’ SAPIEN 3 Transcatheter Heart Valve for patients with aortic valve stenosis who are inoperable or considered high-risk for complications during open-heart surgery.  The third generation of the device includes the addition of a skirt at the base of the valve.

The results of a cohort of the PARTNER II study showed that the SAPIEN 3 valve is clinically superior to the earlier generation devices and minimizes the incidence of paravalvular leakage and stroke. In Edwards Lifesciences’ release, the company’s Corporate Vice President Larry L. Wood comments that “based on extensive research and high quality clinical data, we believe the SAPIEN 3 valve has the potential to transform patient care in the U.S."

According to the FDA announcement, patients who receive the device are at risk of “serious complications from the implantation procedure, such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.” The device should not be used in patients who “cannot tolerate anticoagulation/anti-platelet therapy.” 

Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Blood Platelets, Cardiac Surgical Procedures, Heart Valves, Patient Care, Stroke, United States Food and Drug Administration

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