Pharmaceutical Business review

CryoLife gets FDA clearance for SynerGraft heart valve

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.”