FDA OKs new adhesive to treat burn victims

March 20, 2008

The U.S. Food and Drug Administration approved a medical adhesive -- a fibrin sealant called Artiss -- for use in attaching skin grafts to burn patients.

Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. The FDA said Artiss differs from other fibrin sealants in that it contains a lower concentration of thrombin, allowing surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin.

Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots.

"The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Dr. Jesse Goodman director of the FDA's Center for Biologics Evaluation and Research. "The approval also provides an additional choice for health care professionals in providing burn treatment."

The fibrinogen and thrombin proteins in Artiss are derived from human plasma, collected from FDA-licensed plasma centers. Both proteins undergo purification and virus inactivation treatments to reduce the risk of blood-transmissible infections, the agency said.

Artiss is manufactured by the Baxter Healthcare Corp. of Deerfield, Ill.

Copyright 2008 by United Press International

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