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