FDA Approves Artiss

FDA Approves Artiss Medical Adhesive to Treat Burn Patients

The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.

Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows 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 Jesse L. Goodman M.D., M.P.H., director of 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.

During a multicenter clinical trial, investigators evaluated Artiss for its ability to attach skin grafts on two wound sites for 138 patients. At one test site, the skin graft was fixed with Artiss; at the other test site, the graft was fixed with surgical staples. The results showed that Artiss was, within a statistical error, as good as staples to attain complete wound closure.

Frequent adverse events, seen in both treatment groups, included bleeding and fluid collection in the tissues, both of which are common during skin grafting procedures. Artiss is manufactured by Baxter Healthcare Corporation, Deerfield, Ill.

Posted: March 2008

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Artiss (fibrin sealant (human)) FDA Approval History

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