CryoLife, Inc. announced that it has received US FDA 510(K) approval for its CryoPatch SG pulmonary human cardiac patch. CryoPatch SG is processed with SynerGraft technology intended to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.
CryoPatch SG is designed for repair or reconstruction of the right ventricular outflow tract (RVOT). This surgery is generally 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 that include pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.
CryoPatch SG implantation minimizes the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, when compared to standard processed pulmonary cardiac tissues. There is no data provided to determine the effect of reduced alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.
Patients who receive CryoPatch SG should avoid elevated PRA as some may ultimately require a heart transplant. Though the link between immune response and allograft tissue performance is still unclear, there is evidence that an elevated PRA causes a significant risk to future organ transplant patients. In these patients, an elevated PRA can reduce the number of possible donors for subsequent organ transplants, and increase time on transplant waiting lists.
The introduction of CryoPatch SG represents another step in the broadening applications of the SynerGraft technology to patients and surgeons, said Steven G. Anderson, CryoLife’s president and chief executive officer. CryoPatch SG may offer an attractive tissue reconstruction option for many children born with heart defects.
CryoLife expects that the first CryoPatch SG will be available for shipment late in the third quarter of 2009.