The Edwards SAPIEN 3 Transcatheter Heart Valve(THV)System with Edwards Commander Delivery System consists of a catheter-based artificial heart valve and 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.

The Edwards SAPIEN 3 THV System with Edwards Commander Delivery System was previously approved for the treatment of severe aortic stenosis(a narrowing of the aortic valve that restricts blood flow to aorta, the body's main artery). This approval expands the indications for use to include treatment of severe pulmonary regurgitation, when blood leaks back into the heart from a leaky pulmonary valve, or pulmonary stenosis, when the pulmonary valve narrows and restricts blood flow.