First Decellularized Heart Valve Approved in US

CryoLife, Inc., a biomaterials, medical device and tissue processing company, announced that it has received clearance from the Food and Drug Administration (FDA) for its CryoValve(R) SG pulmonary human heart valve. The valve would implement the companies SynerGraft (SG) technology which is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.
The pulmonary valve directs blood flow from the right ventricle to the lungs. The SynerGraft valve is for use in patients who require replacement of their pulmonary valve because of disease, malformation or malfunction of their own pulmonary valve or as part of another surgical procedure.

Traditionally, when human tissue is recovered from a cadaver for future implantation, it is inspected, cleaned and decontaminated to prevent infection, but the allograft product remains otherwise unchanged. CryoLife Inc. has added a manufacturing step to its CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft (SynerGraft) that decellularizes or removes the tissue's cells and cellular debris. What remains is a scaffold of connective tissue that still functions like a human heart valve, potentially lowering the risk of an immune response and subsequent tissue rejection.

This becomes a popular choice for children because they can avoid the need to take blood-thinning medications on a long-term basis. Also, Allograft heart valves are less likely to calcify than heart valves from a pig or cow.

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