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news.Medical device company CryoLife has received FDA 510(k) clearance for its CryoValve SG pulmonary human heart valve processed with the company's proprietary SynerGraft technology.
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The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native 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.
Steven Anderson, CryoLife’s president and CEO, said: “CryoValve SG may offer an attractive valve replacement option for many children born with heart defects.”