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Decellularized Allograft Heart Valve Approved

Posted on April 29, 2008

FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed. It is called the CryoValve SynerGraft Pulmonary Heart Valve, and is manufactured by CryoLife, Inc.

Allograft valves are recovered from cadavers. Traditionally they are inspected, cleaned and decontaminated, but other than that, they are left unchanged. With the new valve, cells are removed during the manufacturing process. What's left is a scaffold of connective tissue that still functions like a human heart valve, but may be less likely to trigger an immune response and tissue rejection.

Clinical studies on the SynerGraft valve found that it performed at least as well as traditional CryoLife allograft valves with respect to mortality, re-operations, endocarditis, and blood clots.

Additional Information:

FDA Press Release. FDA Clears for Market First Decellularized Heart Valve. February 7, 2008.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01794.html

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