A Medical Device Daily
CryoLife (Atlanta), an implantable biological medical device and cardiovascular tissue processing company, said that it has received a Humanitarian Use Device (HUD) designation from the FDA for its CryoValve SG aortic human heart valve. The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the CryoValve SG aortic human heart valve, which is processed with the company's SynerGraft technology. An approved HDE would allow the company to market the CryoValve SG aortic human heart valve. The company says the SynerGraft technology serves as the foundation for the next generation of implantable biological tissues and 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 aortic human heart valve is intended to be used for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic aortic valves in children from 0 to 21 years of age. The company estimates that up to 1,500 children per year could benefit from this technology if the Company is successful in obtaining an HDE, which is the next step in making these valves commercially available in the U.S.
"The CryoValve SG aortic human heart valve may offer an attractive valve replacement option for many children with aortic valve disease. We plan to immediately begin conducting the bench and animal studies, as well as collecting the human clinical data necessary to apply for the HDE," said Steven Anderson, CryoLife's president/CEO. "This HUD designation is an important first step toward expanding the use of our SynerGraft technology platform, which we believe is the foundation for the next generation of implantable biological tissues."