FDA Approves Baxter’s Artiss

Baxter Healthcare has received FDA clearance for its slow-setting Artiss fibrin sealant 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. Rapid-setting fibrin sealants set in five to 10 seconds.

The FDA approval is based on a multicenter, prospective, randomized, controlled Phase III study comparing the sealant with staples in 138 burn patients requiring skin grafting, Baxter said.