Fibrin Sealant, Artiss: FDA-Approved for Burn Patients

Filed in archive FDA Approvals , News on March 19, 2008

A new medical adhesive - a fibrin sealant - called Artiss for use in attaching skin grafts onto burn patients, has just been approved by the US FDA.

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.

Find more details from the FDA News.