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Epicel(TM) Wins Marketing Approval for Severe Burn Victims
Date:10/29/2007

The process takes approximately 16 days and the skin grafts integrate with surrounding tissue 3 to 4 weeks after surgery.

"Epicel has been the most important advance in burn care for the coverage of large total body surface area burn wounds in this decade," said Dr. Rajiv Sood, medical director, Richard M. Fairbanks Burn Center, Indiana University School of Medicine.

About Epicel

Epicel is indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30 percent. It may be used in conjunction with split-thickness autografts -- another type of skin graft taken from a patient's body to treat the burned area -- or alone in patients for whom these autografts may not be an option due to the severity and extent of their burns. The effectiveness of the device for this use has not been demonstrated.

Epicel is contraindicated in patients with known hypersensitivity to agents used in the manufacture of Epicel. Epicel should not be used in patients with a known history of anaphylaxis to vancomycin or amikacin. Epicel is cultured in media containing vancomycin and amikacin. Trace quantities of these antibiotics may adhere to the Epicel autograft.

Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. The cell culture medium used in the culture of Epicel contains bovine serum and the cells co-cultured with murine 3T3 fibroblasts. The medium used to package and transport Epicel does not contain serum; however, trace quantities of bovine derived proteins may be present. This tissue is intended for autologous use and has not been tested for biohazards. Health care providers should handle this product as if infectious agents are present.

During the Epicel manufacturing, patient's cells are co-cultured with mouse cells. Although the mouse cells have been tested and found to be free of bacteria, fungi and virus, an infection
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SOURCE Genzyme Corporation
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