The Sapien 3 Ultra heart valve has received FDA approval for transcatheter aortic valve replacement (TAVR) in patients with severe, symptomatic aortic stenosis who are considered to be at intermediate or high risk of open-heart surgery, device manufacturer Edwards Lifesciences announced on Dec. 28.
"The advanced Sapien 3 Ultra system features enhancements on the valve and a new delivery system to address the needs of both patients and clinicians, building on our best-in-class performance of Sapien 3 to further advance and improve patient care," Larry L. Wood, Edwards' corporate vice president of transcatheter heart valves, said in a press release. "We look forward to introducing the Sapien 3 Ultra system to U.S. patients."
The device previously received CE mark approval in November. Specifically, the new design includes a heightened outer skirt designed to prevent paravalvular leak and a 14-French expandable sheath, according to Edwards. The valve comes in 20, 23 and 26 millimeter sizes.