CryoLife, Inc. (CryoLife), a biomedical company, has implanted its FDA cleared CryoPatch SG pulmonary human cardiac patch. The first three implantations were performed on pediatric patients at the University of Michigan C.S. Mott Children's Hospital in Ann Arbor, MI by Richard G. Ohye, M.D., associate professor of surgery, division head, pediatric cardiovascular surgery and pediatric cardiac surgeon, University of Michigan Congenital Heart Center.
CryoPatch SG is the third tissue processed using CryoLife’s SynerGraft technology platform to receive FDA clearance. The proprietary technology is designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.
We are very excited that SynerGraft technology is now available in cardiac patch materials for our pediatric patients, said Dr. Ohye, We are hopeful the special processing these patches undergo will lessen the body’s reaction to them and prevent future complications associated with the currently available material.
At CryoLife, our ongoing goal is to provide surgeons and their patients with innovative options that will enhance recovery and restore health, said Steven G. Anderson, CryoLife’s president and chief executive officer. The CryoPatch SG, part of our growing portfolio of SynerGraft products, is an important step toward that goal, as it may offer a tissue reconstruction material that mitigates many of the future health issues faced by children born with heart defects.
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 such as 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 poses a significant risk to future organ transplant patients. In these patients, an increased PRA can decrease the number of possible donors for subsequent organ transplants, and increase time on transplant waiting lists.