CryoLife Announces Implant of First FDA-Cleared SynerGraft(R) Processed Human Pulmonary H...( ATLANTA March 24 /- CryoLife Inc....)

ATLANTA, March 24 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) a biomaterials, medical device and tissue processing company, today announced implantation of the first CryoValve(R) SG pulmonary human heart valve since the product was cleared by the Food and Drug Administration (FDA) in February. The procedure was performed on a patient at St. Louis Children's Hospital in St. Louis, Mo. The CryoValve SG is processed with the Company's proprietary SynerGraft(R) technology, which removes allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.

The CryoValve SG is indicated for the replacement of diseased, damaged, malformed or malfunctioning native pulmonary valves in pediatric and adult patients. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures (RVOT), commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient's defective aortic valve is removed and replaced with his own pulmonary valve. The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.

"CryoValve SG is an attractive valve replacement option for many children born with heart defects," said Steven G. Anderson, CryoLife's president and chief executive officer. "CryoValve SG may also be a good option for patients who underwent pulmonary valve replacement surgery at a young age, but may require another pulmonary valve replacement as they've grown into adulthood."

Charles Huddleston, M.D., chief of pediatric cardiothoracic surgery and professor of surgery at St. Louis Children
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