CryoLife, Inc., Atlanta, GA, announced the US Food and Drug Administration (FDA) has given 510(k) clearance for its CryoValve[R] SG pulmonary human heart valve processed with the company's proprietary SynerGraft technology. The company says its SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.

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, ...