ATLANTA, Feb. 17 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced today that the U.S. Food and Drug Administration (FDA) has cleared a new claim for the CryoValve(R) 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(R) technology, which 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.
The 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 pat
|SOURCE CryoLife, Inc.|
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