The FDA 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, according to the agency.
CryoLife of Kennesaw, Ga., 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, the FDA said. 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, MD, 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, according to the FDA. The agency also said that Allograft heart valves are also less likely to calcify than heart valves from a pig or cow.