FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Epicel® cultured epidermal autograft (CEA)
Manufacturer: Genzyme Biosurgery
Address: 64 Sidney Street, Cambridge Massachusetts 02142
Approval Date:October 25, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf//h990002a.pdf
What is it? Epicel® cultured epidermal autografts (CEAs), or skin grafts, are sheets of autologous keratinocytes (skin cells) used to replace the epidermal, or top layer of skin on severely burned patients. The patient’s own skin cells are grown or cultured from a postage stamp-sized sample of the patient’s own healthy skin. The human keratinocytes are grown on a layer of irradiated mouse cells, making Epicel® a xenotransplantation product as defined by the U.S. Public Health Service (PHS) and FDA.
How does it work? Epicel® replaces the patient’s top skin layer, or epidermis. The skin serves to protect the patient from infection and fluid loss.
When is it used? 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%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
What will it accomplish? In deep dermal or full thickness burns, the outer epidermal layer of the skin and most or all of the dermis (inner layer of the skin) is destroyed. Due to the depth of the injury, regeneration of the skin is greatly reduced. In patients that are severely burned, the patient does not have enough donor skin available to cover the wounds. The physician may need to consider other means of permanent wound closure treatment, such as Epicel®, to treat the patient’s wounds. The Epicel® graft replaces the epidermal or top layer of the skin. This layer of skin is required to close or heal the wound.
When should it not be used? Epicel® should not be used in people with known allergies to agents used in the manufacture of Epicel®. Vancomycin, amikacin, amphotericin B, and bovine (cattle) and murine (mouse) reagents are used in the manufacture of Epicel®. In addition, Epicel® should not be used on infected wounds.
SSPB is not yet available. A link will be established when it has been posted.