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CRYOLIFE, INC. GRANTED FDA APPROVAL TO EXPAND IMPLANT PROGRAM FOR HUMAN ALLOGRAFT HEART VALVES

 ATLANTA, Jan. 5 /PRNewswire/ -- CryoLife, Inc. (NASDAQ-NMS: CRYL), has received approval from the FDA (Food and Drug Administration) on its request to expand the company's investigational device exemption (IDE) for implantation of its cryopreserved allograft human heart valves, CryoValve(R).
 The expanded IDE study provides the company with an aggregate of up to 35 patient implants at each of the ten (10) primary medical centers and up to an aggregate of 1,600 patient implants at 440 secondary centers.
 "The expansion of our IDE allows the company to continue to meet the demands of cardiovascular surgeons for allograft heart valves for use in applications where mechanical or porcine valves would be considered an unsatisfactory substitute," noted Steven G. Anderson, president and chief executive officer of CryoLife, Inc.
 The current expansion represents the third such investigational site waiver granted to CryoLife since IDE studies of CryoValve were instituted in 1992.
 Through December 1993, over 900 physicians have implanted more than 15,500 CryoLife preserved heart valves at medical centers throughout the United States.
 On Nov. 10, 1993, CryoLife, Inc., announced that it had submitted a premarket approval (PMA) application to the FDA for its CryoValve. The application is based upon the clinical experience involving 822 patients enrolled at six (6) primary medical centers. Approval of the PMA would permit the unrestricted U.S. distribution of CryoValve for human implantation.
 Separately, the company announced it had chosen not to consummate the proposed sale of certain equipment to a bone processing operation.
 Founded in 1984, CryoLife, Inc., is a leader in the development and commercialization of technology for ultra-low temperature preservation ("cryopreservation") of viable human cardiovascular and orthopaedic tissues for transplant. The company uses proprietary or patented processes to disinfect, preserve, store and transport human heart valves, veins, and connective tissues for use in cardiac, vascular and orthopaedic surgeries.
 The company is also the exclusive worldwide distributor for Bravo Cardiovascular, Inc., implantable porcine (pig) cardiovascular devices.
 -0- 1/5/94
 /EDITOR'S NOTE: Allograft -- A graft of tissue taken from a donor of the same species as the recipient./
 /CONTACT: Suzanne Gabbert, assistant corporate secretary, CryoLife, 800-438-8285/
 (CRYL)


CO: CryoLife, Inc. ST: Georgia IN: MTC SU:

BR-CM -- AT001 -- 9237 01/05/94 09:51 EST
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Publication:PR Newswire
Date:Jan 5, 1994
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