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CryoLife Announces Implant of First FDA-Cleared SynerGraft(R) Processed Human Pulmonary Heart Valve
Date:3/24/2008

's Hospital, performed the first CryoValve SG implant surgery since FDA clearance of the product in a patient who had undergone two previous allograft implants.

"The new technology provided by this SynerGraft processing was used in this patient in an effort to limit additional valve operations," said Dr. Huddleston. "We are very hopeful that this new valve will be a great thing for the patient and that the outcome with the CryoValve SG implant will last longer than the previous valve surgeries."

At the FDA's request, CryoLife is planning a post-clearance study to seek evidence for the potential and implied long-term benefits of the SynerGraft process. Data to be collected is expected to include long-term safety and hemodynamic function, immune response and explant analysis. CryoLife believes that this information may help it ascertain whether the SynerGraft process reduces the immunogenicity or potential for rejection of the transplanted heart valve and whether the valve recellularizes with the recipients own cells.

Please visit the CryoLife website at http://www.cryolife.com for additional information about the SynerGraft technology and CryoValve SG.

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the United States and Canada. The Company recently received FDA clearance for its CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) Technology. 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. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. The Company also distributes the CryoLife-O'Brien(R) stentless porcine heart v
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SOURCE CryoLife, Inc.
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