Humanitarian device Epicel (cultured epidermal autografts) is authorized for use in adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area 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. The effectiveness of the device for this use has not been demonstrated. Important Safety Information Epicel is contraindicated in patients with a history of anaphylaxis following exposure to vancomycin, amikacin, and amphotericin, as trace quantities of these anti-infective agents may remain in the Epicel autograft. Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. It is contraindicated for use on clinically infected wounds. Important Safety Information Patient Information Instructions for Use Receive Updates from Vericel Find Your Vericel Account Manager MENU What isEpicel? Treatmentwith Epicel ReimbursementSupport Patient CareResources Receive Updates from Vericel Find Your Vericel Account Manager If you are a patient or caregiver, click here Permanent skin covering for burns ≥30% TBSA Learn More Epicel Patient Survival In the Epicel Clinical Experience databases, 954 adult and pediatric patients with a mean TBSA of 67.5% showed: Burn Patient Survival In the 2016 National Burn Repository, 8,870burn patients with a TBSA of 30%–90% showed: 68 % survival 2 The Epicel Experience: One Burn Center's Practice* Regenerate your patient's skin with their own skin cells using Epicel In the Epicel Clinical Experience databases, 453 patients showed a median take rate at discharge of 75% 1 THE EPICEL EXPERIENCE: A 26-YEAR CASE STUDY* *Paid testimonial by an Epicel patient. Individual results may vary. Epicel is indicated for adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area greater than or equal to 30% Consider Epicel for the following patient types Large Burns ≥30% TBSA Limited suitable harvest sites Autograft for key functional areas Click here to learn more about treatment with Epicel Receive Updates from Vericel Find Your Burn Therapy Specialist Specialists are available to answer reimbursement questions about Epicel and the CEA procedure. 1-800-CEA-SKIN (1-800-232-7546) [email protected] Epicel is widely reimbursed and included on a majority of national insurance plans. Click here to learn more about Epicel reimbursement Humanitarian Device Epicel (cultured epidermal autografts) is authorized for use in adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area 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. The effectiveness of the device for this use has not been demonstrated. Important Safety Information Epicel is contraindicated in patients with a history of anaphylaxis following exposure to vancomycin, amikacin, and amphotericin, as trace quantities of these anti-infective agents may remain in the Epicel autograft. Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. It is contraindicated for use on clinically infected wounds. Because Epicel is manufactured with and contains residual amounts of murine cells, FDA considers it a xenotransplantation product. Therefore, recipients should not donate whole blood, blood components, source plasma, source leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans because there is a potential risk of carrying an infection that is transmitted from mouse cells to humans. Squamous cell carcinoma (SCC) has been reported in patients with burn injury after being grafted with Epicel. Although SCC is a known complication of burn scars, the role of Epicel in the causation of SCC cannot be excluded. The Epicel product is intended solely for autologous use. Patients undergoing the surgical procedure associated with Epicel are not routinely tested for transmissible infectious diseases. Discontinue use if the patient shows evidence of allergic reaction. If clinical signs of infection are present or develop, do not apply Epicel until the infection is adequately treated. The effectiveness of Epicel has not been proven in clinical studies. The long-term safety of Epicel is unknown. Over the past 27 years, the mortality from all causes was 13% before hospital discharge. Men and women who intend to have children should be advised that the effects, if any, of Epicel on fetal development have not been assessed. In addition, the safety of Epicel has not been studied in pregnant and nursing women. Patient information supplied by attending burn teams from 1989 to 1996 reported the adverse events of highest incidence as: death (13%), infection (13.8%), graft tear (7.8%) or graft blister (4.2%) and drainage (3.3%). Some of these events may have been due to the underlying burn injury and not the device itself. From June 1998 through September 2015 adverse events received by Genzyme Biosurgery (predecessor in interest to Vericel) and Vericel Corporation were similar to the previously identified adverse events. Events that were reported in ≥ 1% of patients included multi-organ failure (6.6%), sepsis (5.2%) infection (4%) and skin graft failure/graft complication (2.7%). The relationship of these events to Epicel has not been established. Please see Patient Information and Instructions for Use for more information References Hickerson WL, Remmers AE, Recker DP.  Twenty-Five Years’ Experience and Beyond with Cultured Epidermal Autografts for Coverage of Large Burn Wounds in Adult and Pediatric Patients, 1989-2015. J Burn Care Res. 2019;40(20):157-165 American Burn Association National Burn Repository 2016 Report version 12:0:10 Mathew Varkey, Jie Ding, Edward E. Tredget. Advances in Skin Substitutes – Potential of Tissue Engineered Skin for Facilitating Anti-Fibrotic Healing. J. Funct. Biomater. 2015, 6, 547-563 Bishara S. Atiyeh, Michel Constagliola. Cultured epithelial autograft (CEA) in burn treatment: Three decades later. Burns, November 2006;40 Rajiv Sood, MD, David Roggy, RN, Madeline Zieger, PA-C, et. al Cultured Epithelial Autografts for Coverage of Large Burn Wounds in Eighty-Eight Patients: The Indiana University Experience, J Burn Care Res, 2010;31:559-568 Williams FN, Herndon DN, Jeschke MG. The hypermetabolic response to burn injury and interventions to modify this response. Clin Plast Surg. 2009 Oct;36(4):583-96 Cuono C, Langdon R, McGuire J. Use of cultured epidermal autografts and dermal allografts as skin replacement after burn injury. Lancet. 1986;1:1123-4 Rajiv Sood, MD, Beretta Craft-Coffman, PAC, Paula Fillari, RN, CCRN. Surgical Guidelines for Epicel ® cultured epidermal autografts (CEA). 2015 This site is intended for United States residents who are 18 years of age or older. Epicel ® , Vericel ® , and the Vericel logo are registered trademarks of Vericel Corporation. ©2023 Vericel Corporation. All rights reserved. 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