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A blood-clotting protein used to help control bleeding during surgery has been approved by the FDA.
Evithrom is the first human thrombin approved since 1954, and is the only such product currently licensed for use in the USA.
It is derived from human plasma obtained from donors who have been carefully screened and tested.
The product is then subjected to further tests to reduce the risk of patients contracting diseases following the transfusion.
Evithrom is used to stop oozing and minor bleeding from capillaries and small veins, and when bleeding cannot be controlled by standard surgical techniques.
The product is applied to the surface of affected tissue and may be used in conjunction with a gelatin sponge.
In a clinical trial involving several hundred patients, Evithrom was found to be comparable to cattle-derived thrombin in both safety and effectiveness.
Jesse Goodman, the director of FDA’s Center for Biologics Evaluation and Research, said: “The approval of Evithrom offers an important additional option for surgeons and their patients to help control surgical bleeding.
“Surgeons will now be able to choose between human thrombin and thrombin derived from cattle plasma.”
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