CryoLife, Inc. Reports CDC Provides Additional Information Relating To Rare Bacterial Infection Case

December 14, 2001 at 2:32 PM EST
ATLANTA, Dec 14, 2001 /PRNewswire via COMTEX/ -- CryoLife, Inc. (NYSE: CRY), a life- science company involved in the development and commercialization of cryopreserved and tissue-engineered implantable heart valves, vascular and orthopaedic reconstruction grafts, and surgical adhesives, today announced that the U. S. Centers for Disease Control and Prevention (CDC), has completed its testing of CryoLife-processed tissue from the donor of condyle tissue implanted in the Minnesota knee surgery patient who died on November 11, 2001. The human donor tissue was delivered by CryoLife to the CDC as part of the Company's cooperative efforts in the investigation of the knee surgery patient's death. The CDC confirmed that the tissue examined contained the rare bacterium Clostridium sordellii. The tissue examined by the CDC had not been released for transplant and was examined by them subsequent to its implant expiration date.

Neither the U.S. Food and Drug Administration (FDA) nor the CDC, after conducting thorough inspections of the CryoLife processing facilities, have recommended or suggested changes in CryoLife's processing protocols of human tissues.

Steven G. Andersen, President and Chief Executive Officer of CryoLife, Inc. commented, "The safety and efficacy of our services, and the safety of patients, is of paramount concern to CryoLife. We are pleased to report that all other recipients of tissue from the donor of the condyle tissue are doing well with no evidence of Clostridium sordellii infection. In the seventeen years since its founding CryoLife has processed tissue from over 60,000 donors without a single known incident of Clostridium sordellii infection." Anderson also noted that, "This incident has not had an adverse effect on CryoLife's orthopaedic revenues, which remain strong."

Founded in 1984, CryoLife, Inc. is the leader in the development and commercialization of implantable living human tissues for use in cardiovascular, vascular and orthopaedic surgeries throughout the United States and Canada. The Company's BioGlue(R) surgical adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels and is CE marked in the European Community and approved in Canada and Australia for use in vascular and pulmonary sealing and repair. The Company also manufactures the SynerGraft(R) heart valve, the SynerGraft vascular graft, the world's first tissue-engineered heart valve and vascular replacements, and the CryoLife-O'Brien(R) and CryoLife-Ross(R) stentless porcine heart valves, which are CE marked for distribution within the European Community. The human heart valves and vascular grafts processed by CryoLife using the SynerGraft technology are distributed in the U.S. under the trade names of CryoValve(R)SG and CryoVein(R)SG, respectively.

For additional information about the company, visit CryoLife's web site: http://www.cryolife.com .

    Contact:  Roy Vogeltanz
              Vice President, Corporate Communications
              (800) 438-8285