FDA approves novel allograft product

The U.S. Food and Drug Administration has cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed.

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.

"Today's clearance is a promising advance in allograft products," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA welcomes innovations in manufacturing that provide more medical options for patients."

Allograft (human) heart valves are popular choices for children because they avoid the need to take blood-thinning medications on a long-term basis. Allograft heart valves are also less likely to calcify than heart valves from a pig or cow.

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.

The FDA cleared the SynerGraft valve based on clinical data comparing 342 SynerGraft valves (implanted between the years 2000 and 2004) to 1,246 traditional allograft heart valves sold by the company. The data included information on mortality, device-related re-operations, structural valve deterioration, endocarditis (an inflammation of the heart's inner lining) and blood clots. The FDA found that the SynerGraft valve performed at least as well as traditional allograft valves.

CryoLife is based in Kennesaw, Ga.