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CryoLife Announces Implants of First FDA-Cleared SynerGraft(R) Processed Human Cardiac Patch Material
Date:8/18/2009

dicated for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.

Implantation of the CryoPatch SG reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to standard processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.

Avoiding elevated PRA is important for patients receiving CryoPatch SG as some may ultimately require a heart transplant. While the link between immune response and allograft tissue performance is still being debated, there is evidence that an elevated PRA poses a significant risk to future organ transplant patients. In these patients, an increased PRA can decrease the number of possible donors for subsequent organ transplants, and increase time on transplant waiting lists.

Please visit the CryoLife website at www.cryolife.com for additional information about the SynerGraft technology and CryoPatch 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 U.S. and Canada. The Company's CryoValve((R)) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft((R)) technology, has FDA 510(k) clearance for the replacement of di
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SOURCE CryoLife, Inc.
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