FDA grants CryoLife 510(k) clearance for shelf-life extension of CryoValve SG pulmonary heart valve

CryoLife, Inc., (NYSE: CRY) a biomaterials, medical device and 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 CryoValve® SG pulmonary human heart valve processed with the Company's proprietary SynerGraft® technology.  CryoLife's SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.  This biotechnology is used by cardiovascular surgeons for complex reconstructive surgeries, including those performed on children.

"This shelf-life extension to five years simplifies the purchasing decisions and tissue inventory management issues presented to hospitals by the previous one-year shelf life," said Steven G. Anderson, CryoLife's president and chief executive officer.  "Additionally, the extended shelf life will allow us more flexibility to increase the percentage of heart valves processed utilizing the SynerGraft technology.  This will serve to make this technology available to more patients."

The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native 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.

At FDA's request, CryoLife is continuing research on SynerGraft processed pulmonary heart valves by conducting a post-clearance study to seek evidence for the potential and implied long-term benefits.  Data to be collected will include long-term safety and hemodynamic function, immune response, and explant analysis.  CryoLife believes that this information may help it ascertain whether the SynerGraft process reduces the immunogenicity of the transplanted heart valve and allows the valve to recellularize with the recipient's own cells.