'Decellularized' Heart Valve Approved
THURSDAY, Feb. 7 -- The U.S. Food and Drug Administration has approved the first replacement heart valve from donated human tissue, in which the tissue's cells have been removed.
Removing the tissue's cells and cellular debris is designed to lower the risk of an immune response from the body and subsequent tissue rejection, the FDA said in a statement.
Cyrolife Inc's CyroValve SynerGraft pulmonary valve is 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.
Clinical studies compared results of 342 of the SynerGraft valves to 1,246 traditional valves. The FDA said it found that the new valves performed at least as well as the traditional ones.
The FDA has more about this approval.
Posted: February 2008