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

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.

Important Safety Information

ARTISS (Fibrin Sealant (Human))

ARTISS is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations.

ARTISS is not indicated for hemostasis.

Do not inject ARTISS directly into blood vessels. Intravascular application of ARTISS may result in life-threatening thromboembolic events.

Do not use ARTISS in individuals with a known hypersensitivity to aprotinin.

ARTISS is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Apply ARTISS as a thin layer. Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.

Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure and pruritus.

Please see ARTISS Prescribing Information for full prescribing details.

About Baxter

Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical cond

SOURCE Baxter Healthcare Corporation
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