Aug 9 2010
CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for a five-year shelf-life on its CryoPatch® SG pulmonary human cardiac patch processed with the Company's proprietary SynerGraft® technology. CryoLife's SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.
"This shelf-life extension allows us to make this advanced technology available to more patients," said Steven G. Anderson, CryoLife's president and chief executive officer. "Further, the extended five-year shelf life will simplify the purchasing decisions and tissue inventory management for hospitals."
CryoPatch SG is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
Implantation of the CryoPatch SG reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to standard processed pulmonary cardiac tissues. 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. While the link between immune response 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.