New tissue adhesive allows for placement of skin grafts without staples or sutures

COMPTON, UK  20th March 2009 – Baxter Healthcare Ltd announced today the approval of ARTISS, the first and only slow-setting fibrin sealant indicated as a tissue glue to seal subcutaneous tissue in plastic, reconstructive, and burn surgery, as a replacement or an adjunct to sutures or staples. In addition, ARTISS is indicated as an adjunct to haemostasis on subcutaneous tissue surfaces.   The tissue adhesive was developed using Baxter’s established fibrin sealant technology platform and it is the newest product in the company’s expanding BioSurgery portfolio.
 

ARTISS provides for the delayed setting and controlled manipulation of skin grafts for approximately 60 seconds to allow for proper graft placement, as contrasted with rapid-setting fibrin sealants, which set in 5 to 10 seconds.  Skin grafts can be affixed without the use of staples or sutures.
 

“ARTISS is an effective alternative to staples to reduce discomfort among burn patients requiring skin grafts,” said Bernard Cheru M.D., Director Baxter BioSurgery Europe. “With this new sealant Baxter is continuing to expand its scientific leadership in specialty BioSurgery products, serving needs of patients and healthcare providers.”

The approval is based on Phase III study results, which were also published in the March/April 2008 issue of The Journal of Burn Care and Research.  The multi-center, prospective, randomized, controlled and blinded study compared the use of ARTISS to staples in 138 burn patients requiring skin grafting.  ARTISS is well tolerated and effective for attaching skin grafts with outcomes at least as good as staple fixation, according to the Phase III study.

About ARTISS
ARTISS is indicated as a tissue glue to seal subcutaneous tissue in plastic, reconstructive and burn surgery, as a replacement or an adjunct to sutures or staples. In addition, ARTISS is indicated as an adjunct to haemostasis on subcutaneous tissue surfaces. ARTISS is not indicated to replace skin sutures intended to close surgical wounds. ARTISS alone is not indicated for the treatment of massive and brisk arterial or venous bleeding. 

About Baxter
Baxter Healthcare Ltd is the principal UK operating subsidiary of Baxter International Inc. (NYSE:BAX). Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals, and biotechnology to create products that advance patient care worldwide.

ARTISS is a trademark of Baxter International Inc.