USFDA approves Edwards SAPIEN 3 Transcatheter Heart Valve System - P140031/S085

The SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System of Edward, both consist of an artificial catheter-based aortic heart valve and accessories used for implantation of the valve without open-heart surgery.

The doctor compresses the products and it is placed on the end of a tube-like device called a balloon catheter after inserting it through an artery in the leg, neck, or through a small cut between the ribs. The catheter passes the blood vessels till it reaches the diseased aortic valve. Expansion of valve by a balloon leads it to anchoring to the diseased valve. Once the new valve takes the place, it functions the same as the old valve.

The products are used in patients with diseased aortic heart valve caused due to calcium build up, which causes the valve narrowing and restricting of blood flow through the valve.

These should not be used in patients with heart infection or cannot tolerate blood thinning.