||cultured epithelial autograft|
||Interactive wound and burn dressing containing a live xenogeneic component.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.
||Epicel cultured epidermal autografts (CEA) is an aseptically processed wound dressing composed of the patient?s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with stainless steel surgical clips and measures approximately 50 cm2 in area.
||Patient's own cells are in vitro cultivated and expanded in number into a graft/dressing design in sufficient size to facilitate coverage of the burn injury.
||Entire integumentary (skin) system
|| General & Plastic Surgery
Office of Device Evaluation
Division of Surgical Devices
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
HDE - Humanitarian Device Exemption
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible