CryoLife announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its CryoValve(R) SG pulmonary human heart valve processed with the Company’s proprietary SynerGraft technology. CryoLife’s proprietary SynerGraft technology is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.
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.
“CryoValve SG may offer an attractive valve replacement option for many children born with heart defects,” said Steven G. Anderson, CryoLife’s president and chief executive officer. “CryoValve SG may also be a good option for patients who have undergone valve replacement surgery as young children, but may require another valve replacement as they’ve grown into adulthood.”
“Children born with heart defects often face frequent and challenging surgeries,” stated John W. Brown, M.D., professor of Cardiothoracic Surgery, Indiana University School of Medicine, Indianapolis, Ind. “For certain heart defects, CryoValve SG may give these kids a great opportunity to live active, normal lives. As a surgeon, I’m very excited to be able to offer them and their families this treatment option.”
At FDA’s request, CryoLife is planning a post-clearance study to seek evidence for the potential and implied long-term benefits of the SynerGraft process. Data to be collected is expected to 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 recellularizes with the recipients own cells.
CryoLife will be using the SynerGraft technology for the majority of its pulmonary valve processing and anticipates that the first CryoValve SG may be available for shipment late in the first quarter of 2008.