The FDA has given approval to CryoValve® SG pulmonary human heart valve, an allograft based on CryoLife‘s SyneGraft® technique that removes cells and cell fragments from cadaveric heart valves. The remaining matrix is thought to be less prone to attack by the immune system.
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.
FDA press release: FDA Clears for Market First Decellularized Heart Valve
CryoLife press release: CryoLife Receives FDA 510(k) Clearance for SynerGraft(R) Processed Human Pulmonary Heart Valves
Product page: CryoLife : CryoValve® SG Pulmonary Human Heart Valve