CryoLife gets FDA 510 (k) clearance for CryoPatch SG pulmonary human cardiac patch shelf-life extension.
CryoPatch is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT), a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoLife SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
The company said implantation of the CryoPatch SG reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) up to one year, compared to standard processed pulmonary cardiac tissues. It also emphasized that data have not been provided to evaluate the effect of reduced alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the Cryopatch SG.
Avoiding elevated PRA is important for patients receiving CryoPatch SG as some may ultimately require a heart transplant, CryoLife warned. While the link between immune responses and allograft tissue performance is still being debated, there is evidence that an elevated PRA can pose a significant risk to future organ transplant patients. For additional information go to CryoLife's Web site: http://www.cryolife.com or contact Dana Hartline, Vice President, Edelman--Ph: (404) 832-6358 or e-mail: Dana.Hartline@edelman.com
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|Date:||Aug 1, 2010|
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