Edwards CVS Wins U.S. OK to Market 2 New Heart Valves

IRVINE — Edwards CVS, a division of Baxter Healthcare Corp., said Tuesday that it has won federal approval to market two artificial heart valves.

One of the devices, used to replace a degenerated aortic valve, is the first new artificial heart valve approved by the Food and Drug Administration in five years, the company said. The second device, which replaces the mitral valve, is a revised version of a valve originally approved in 1986.

Both valves are made of bovine pericardial tissue, the thin membrane surrounding a cow’s heart. About 40% of artificial valves sold in the United States are tissue valves, while 60% are mechanical valves.

Tissue valves can eliminate a heart patient’s need for long-term anticoagulant drug therapy, the company said. Anticoagulants, blood-thinning agents, are used to prevent clotting in patients who have been implanted with mechanical valves.

Irvine-based Edwards is one of the nation’s leading manufacturers of both mechanical and tissue heart valves. Baxter, based in Deerfield, Ill., introduced the world’s first artificial heart valve in 1960.