| Device |
cultured epithelial autograft |
| Definition |
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. |
| Physical State |
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. |
| Technical Method |
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. |
| Target Area |
Entire integumentary (skin) system |
| Review Panel |
General & Plastic Surgery |
|---|
| Product Code | OCE |
|---|
| Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
