FDA approves novel Allograft product

Especially popular for children as the process can avoid the use of long term blood thinking products for a long term basis, according to the article...and potentially less calcification. BD

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. 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.