CryoLife gets FDA clearance for new immune response claim for its pulmonary human heart valve.CryoLife, Inc., Atlanta, GA, announced that the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 of the CryoValve SG. The company says the new claim was validated from data provided from three clinical studies and a comprehensive review of the scientific literature on allograft allograft: see transplantation, medical. heart valves showed 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. CryoLife notes that the effect of reduced alloantibodies 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 heart valve is indicated for the replacement of diseased, damaged, malformed mal·formed adj. Abnormally or faultily formed. or malfunctioning native or prosthetic pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract A ventricular outflow tract is a portion of either the left or right ventricle of the human heart through which blood passes in order to enter the great arteries. The right outflow tract is an infundibular extension of the ventricular cavity, which connects to the pulmonary reconstruction procedures, commonly performed in children with congenital heart defects Congenital heart defects Congenital means conditions which are present at birth. Congenital heart disease includes a variety of defects that babies are born with. Mentioned in: Heart Failure, Heart Surgery for Congenital 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. Contact: www.cryolife.com |
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