CryoLife, Inc., an implantable biological medical device and cardiovascular tissue processing company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CryoPatch® SG pulmonary human cardiac patch. CryoPatch SG is processed with the Company’s proprietary SynerGraft technology designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.
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 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.
“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.”
Management estimates that the U.S. market for CryoPatch SG and other tissues and products for the indications listed above is $15 million. CryoLife anticipates that the first CryoPatch SG will be available for shipment late in the third quarter of 2009.
In February 2008, the Company received a 510(k) clearance from the FDA for its CryoValve(®) SG pulmonary human heart valve. CryoValve SG is indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures (RVOT), commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient’s defective aortic valve is removed and replaced with his own pulmonary valve. The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.
Source: CryoLife, Inc