WEDNESDAY, Dec. 17, 2014 (HealthDay News) -- A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.
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The system uses controlled exposure to ultraviolet light and a germ-targeting chemical called amotosalen, the agency said. The plasma is then purified to remove the chemical and any byproducts.
While the system has proven effective, no system or device has been shown to eliminate all germs. The Intercept system hasn't been effective, for example, in eliminating the human parvovirus B19 and spores formed by certain bacteria, the FDA said.
The system's clinical safety and effectiveness were evaluated in studies involving more than 700 people. Side effects were comparable to those among people who received untreated plasma, the agency said.
The Intercept system is marketed by Cerus Corp., based in Concord, Calif.
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