FDA OKs New Type of Human Heart Valve
CryoValve SG May Lower the Risk of Infection and Donor Rejection
The FDA approved this week a new type of human heart valve that may be safer than traditional replacement heart valves.
CryoLife Inc., a biomaterials, medical device, and tissue processing company, is marketing the valve as the CryoValve SynerGraft Pulmonary Valve or CryoValve SG for short.
The valve is different from other donated human heart valves in that the cells have been removed through a process called decellularization. The connective tissue, which still functions like a human heart valve, remains. Decellularization may lower the risk of infection and the odds that the recipient's body will reject the valve.
Human heart valves are often given to children born with heart defects because they eliminate the need to take blood-thinning medications on a long-term basis. They are also less likely to calcify than heart valves from a pig or cow.
"CryoValve SG may offer an attractive valve replacement option for many children born with heart defects, Steven G. Anderson, CryoLife's president and CEO, says in a news release. "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."
The CryoValve SG is designed for people who need to have their pulmonary valve replaced because it is diseased, damaged, malformed, or not functioning properly. The pulmonary valve directs blood flow from the right ventricle to the lungs.
It is expected to be available in early spring 2008.