FDA OKs Edwards’ Cow-Tissue Heart Valves

Edwards Lifesciences Corp., the No. 1 maker of heart valves made of animal tissue, said Thursday the U.S. Food and Drug Administration approved its valve made from cow tissue.

Shares of the Irvine company, which was spun off from Baxter International Inc. in April, rose 1.94 to 26.25 after hitting a record $26.38 on the New York Stock Exchange earlier in the session.

Edwards executives expect the valve to boost sales significantly in the company’s cardiac surgery division, which includes heart repair products and valves.

The valve is made of tissue from the pericardial sac that surrounds a cow’s heart, combined with elements of a mechanical valve. That gives the product a more precise fit and makes it more durable than valves made of pig tissue, the company said.

“Tissue valves tend to have an advantage over mechanical valves because patients don’t have to go on a lifetime treatment of blood-thinning drugs,” said Chief Executive Michael Mussallem.

The valve, which is designed to replace the heart’s mitral valve, has been sold in Europe since 1984, the company said.

Mechanical valves run a greater risk of causing a patient’s blood to clot, requiring the blood thinners, so more doctors are switching to valves made of animal tissue. About 300,000 people worldwide undergo open-heart surgery each year to treat malfunctioning or diseased heart valves, according to the company.

Clinical studies showed the cow-tissue valve lasts about 15 years in humans. Valves made with pig tissue generally last about 10 years, the company said.