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CryoLife Submits Human Tissue Plan

Oct 8, 2002 | AP

CryoLife Inc. Tuesday said it submitted plan to the Food and Drug Administration outlining steps to prevent contamination of the human tissue it distributes for transplants.

The FDA in August ordered CryoLife to stop distributing cadaver tissue after its products for implants were linked to a death and numerous serious infections.

"We are processing tissue under the terms of the interim agreement and we are on schedule with the FDA," the Kennesaw, Ga., company said.

Shares of CryoLife closed at $2.69 Tuesday on the New York Stock Exchange, up 54 cents, or 25 percent.

Last month, the FDA, under an interim agreement, agreed to allow CryoLife to resume limited distribution of processed human tissue for urgent cases in which no alternatives are available.

CryoLife said Tuesday it continues to process life- and limb-saving cardiac and vascular tissues under the interim agreement. Heart valves were not affected by the original FDA order and have not been subject to the recall order or the interim agreement.

CryoLife and other processors of human tissue have received increased attention from the FDA and the Centers for Disease Control and Prevention since late last year, when a patient died from an infection after tissue provided by CryoLife was implanted in his knee during a routine operation. The FDA is preparing rules slated to be ready next year to govern how tissues should be handled and stored, and the CDC is surveying doctors to find out how many times patients have received infected tissue. The CDC has identified 54 such cases so far, including 25 from CryoLife.

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