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Article: CryoLife gets FDA clearance for new immune response claim for its pulmonary human heart valve.
- Article from:
- Transplant News
- Article date:
- March 1, 2009
CopyrightCOPYRIGHT 2009 Transplant Communications, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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CryoLife, Inc., Atlanta, GA, announced that the US Food and Drug Administration (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 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 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 ...