CryoLife, an implantable biological medical device and cardiovascular tissue processing company, has received a humanitarian use device (HUD) designation from the FDA for its CryoValve SG aortic human heart valve.
According to the Atlanta-based company, 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 its SynerGraft technology. An approved HDE would allow the company to market the CryoValve SG aortic human heart valve.
The company said that 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 zero to 21 years of age.
The SynerGraft technology serves as the foundation for the next generation of implantable biological tissues and is designed to remove allergenic donor cells and cellular remnants from the valve without compromising the collagen matrix, CryoLife said.