Heart Disease

FDA requests additional information on decellularized heart valves

Published in Heart Disease Weekly, March 14th, 2004

CryoLife, Inc., (CRY), a human tissue processing and bio-surgical device company, announced that the U.S. Food and Drug Administration (FDA) has requested additional information be provided to support the 510(k) premarket notification for the CryoValve SG decellularized human heart valves.

The company plans to work with the FDA to review and address their requirements.

Since February 2003, the company has been processing tissues without the decellularized SG technology.

Revenues from CryoValve SG processed heart valves were not included in the company's financial guidance for 2004; therefore, the company's previously announced...

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Source: Heart Disease Weekly (2004-03-14)

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