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New heart valve may lower risk of rejection

FDA-approved device is made from human tissue with skin cells removed

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.

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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.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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