"The introduction of CryoPatch SG represents another step in the broadening applications of the SynerGraft technology to patients and surgeons," said Steven G. Anderson, CryoLife's president and chief executive officer. "CryoPatch SG may offer an attractive tissue reconstruction option for many children born with heart defects."
Management estimates that the U.S. market for CryoPatch SG and other tissues and products for the indications listed above is $15 million. CryoLife anticipates that the first CryoPatch SG will be available for shipment late in the third quarter of 2009.
In February 2008, the Company received a 510(k) clearance from the FDA for its CryoValve((R)) SG pulmonary human heart valve. CryoValve SG is indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. 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.
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 diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The Company's BioGlue((R)) Surgical Adhesive is FDA approved as an adjunct to sutures and stapl
|SOURCE CryoLife, Inc.|
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