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news.Baxter Healthcare has received the FDA approval of Artiss, the slow-setting fibrin sealant indicated for use in adhering skin grafts in adult and pediatric burn patients.
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Artiss was developed using Baxter’s proven fibrin sealant technology platform and is the newest agent in the company’s expanding BioSurgery portfolio. It is a biologically active sealant consisting of human fibrinogen and low concentration human thrombin. Artiss 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.
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.
Ron Lloyd, general manager, BioSurgery, said: “Artiss is a safe and effective alternative to staples, reducing discomfort among burn patients requiring skin grafts.”