FDA Approves Fibrin Sealant for Burns

Filed in archive Drugs, Vaccines and Therapeutics on March 24, 2008

The US FDA has approved Baxter Pharmaceuticals' new medical adhesivecalled Artiss, the first and only slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients.

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.

This approval is based on amulti-center, prospective, randomized, controlled and blinded Phase III study involving 138 burn patients requiring skin grafting. ARTISS has been shown to be safe and effective for attaching skin grafts and is as good as staple fixation.

ARTISS will be launched at the American Burn Association (ABA) 40th Annual Meeting to be held on April 29 - May 2, 2008 in Chicago.

Source: Baxter