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Cryolife Announces FDA Clearance For New Immune Response Claim Of CryoValve SG Pulmonary Human Heart Valve

CryoLife, Inc. announced that the US FDA has cleared a new claim for the CryoValve SG pulmonary human heart valve. The new labeling claim relates to reducing a component of the immune response in recipients of the CryoValve SG. CryoValve SG pulmonary human heart valve is processed with the company's proprietary SynerGraft technology. This human heart valve is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. The new claim relates to the fact that data from three company-sponsored clinical studies and a comprehensive review of the scientific literature on allograft heart valves shows that implantation of the CryoValve SG reduces the risk of inducing HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to the standard- processed pulmonary human heart valve. The effect of reduced alloantibodies, however, on the long-term durability, or long-term resistance to rejection by the patient, of the CryoValve SG has not yet been clinically proven. The company has documented the implantation of more than 1,800 CryoValve SG pulmonary human heart valves. CryoValve SG pulmonary human heart valve 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 or her own pulmonary valve. The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.