The U.S. Food and Drug Administration (FDA) has approved the first replacement heart valve from donated human tissue, which has been stripped of its cells by a proprietary process. It is also considered to be less immunogenic than conventional allograft valves have been approved by the FDA.

Its manufacturer, CryoLife uses the decellularization process on its CryoValve SynerGraft (SG) pulmonary valve that still functions like a human heart valve, potentially lowering the risk of an immune response and subsequent tissue rejection, the agency said in a February 7 statement.

The process aims at lowering the risk of an immune response from the body and subsequent tissue rejection. It is also designed for patients who need a replacement for a pulmonary valve because of disease, malformation or malfunction. The pulmonary valve directs blood flow from the heart's right ventricle to the lungs.

According to a press release by a CryoLife, "The SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed, or malfunctioning native pulmonary valves."

"The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures, commonly performed in children with congenital heart defects," it added.