New heart valve may lower risk of rejection

updated 3:29 p.m. ET Feb. 7, 2008

WASHINGTON - The Food and Drug Administration on Thursday approved a new heart valve from CryoLife that may lower the risk of rejection.

FDA said the Atlanta-based company's device is the first heart valve made from human tissue that has had the skin cells removed. Normally, when human tissue is removed from a cadaver to make a heart valve it is cleaned to prevent infection, but otherwise remains unchanged.

The CryoValve SynerGraft Pulmonary Valve goes through an extra step to remove tissue cells, leaving a scaffold-like valve, which the FDA said may lower the chance of triggering the body's immune system.

Heart valves made from human tissue are often used on children because they don't require patients to take blood thinners on a long-term basis. Other types of valves are made from pigs or cows.

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