Baxter Announces FDA Approval of ARTISS Slow-Setting Fibrin Sealant in Treatment of Burn Patients

Spray and Go...bandages and wound sealant...no more stitches...60 seconds to dry...use for skin grafts and burn patients...BD

DEERFIELD, Ill., March 20 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation announced today the U.S. Food and Drug Administration (FDA) approval of ARTISS (Fibrin Sealant (Human)), the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients. ARTISS was developed using Baxter's proven fibrin sealant technology platform and is the newest agent in the company's expanding BioSurgery portfolio. ARTISS allows for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds, relative to rapid-setting fibrin sealants, which set in five to 10 seconds. Skin grafts can be fixed without the use of staples or sutures, which may help reduce post-operative complications and patient anxiety about pain during staple removal. Baxter will launch ARTISS at the American Burn Association (ABA) 40th Annual Meeting held April 29 -- May 2, 2008 in Chicago.

ARTISS is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin. It will be available in two forms: a pre- filled syringe (frozen) formulation and a lyophilized form. Both dosage forms, once prepared and ready to use, can be sprayed, thus enabling application in a thin and even layer.