The US Food and Drug Administration (FDA) has approved the Sapien 3 Ultra system (Edwards Lifesciences) for transcatheter aortic valve replacement in patients with severe, symptomatic aortic stenosis at intermediate or greater risk for open-heart surgery.

Severe symptomatic aortic stenosis carries a poor prognosis. Until relatively recently, surgical aortic valve replacement has been the standard of care in adults with severe symptomatic aortic stenosis.

However, the risks associated with surgical aortic valve replacement are increased in elderly patients and those with concomitant severe systolic heart failure or coronary artery disease, as well as in patients with comorbidities such as cerebrovascular and peripheral arterial disease, chronic kidney disease, and chronic respiratory dysfunction.

Transcatheter aortic valve replacement (TAVR) has been developed as an alternative to the surgical approach in this high-risk population. In 2002, Allen Cribier implanted the first human TAVR using an equine valve with a balloon-expandable frame.

Sapien 3 Ultra system

The currently available devices include the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) and the balloon-expandable Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California).

According to the company, the Sapien 3 Ultra system (valve sizes 20, 23, and 26 mm) features enhancements to the valve and a new delivery system and sheath. The valve has a heightened outer skirt designed to eliminate the paravalvular leak.

The Sapien 3 Ultra delivery system consists of a new low-profile 14-French Axela expandable sheath and introduces an "on balloon" design, eliminating the need for valve alignment during the procedure.

"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 Wood, Edwards' corporate vice president, transcatheter heart valves, said in a news release announcing approval.

"The Edwards Sapien 3 Ultra system provides meaningful technology improvements that help further optimize the transcatheter aortic valve replacement procedure, adding simplicity and advancing patient care," John Webb, MD, director, interventional cardiology and cardiac catheterization laboratories, St Paul's Hospital, Vancouver, Canada, and professor of cardiology, University of British Columbia, who is a consultant for Edwards Lifesciences, said in the release.

The company received CE marking for the Sapien 3 Ultra system for transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients in November 2018.