CryoLife, a medical device and tissue processing company, has received FDA 510(k) clearance for a five-year shelf-life extension on its CryoValve SG pulmonary human heart valve processed with the company's SynerGraft technology.
CryoLife said that its 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 is used by cardiovascular surgeons for complex reconstructive surgeries, including those performed on children.
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 has been 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.
Steven Anderson, president and chief executive officer of CryoLife, said: “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. 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.”