![]() The updated indication no longer constrains treatment of full-thickness injuries based on an upper limit of 50 percent TBSA. “There has been a high unmet need for alternative treatments for pediatric burns, so I am pleased that the RECELL System, with its proven efficacy to accelerate the burn healing process with less donor skin requirements, is now available as an FDA-approved treatment option for my younger burn patients.”įor full-thickness burns, the initial PMA study of RECELL treatment was limited to patients with burn wounds up to 50 percent TBSA injuries, which was also reflected in the initial FDA-approved RECELL indication. “Skin grafting, which is currently the standard of care used to treat many pediatric burns, is painful, results in an additional wound, can be disfiguring, and may result in additional complications as a child grows,” says Anjay Khandelwal, MD, FACS, FICS, Akron Children’s Hospital Burn Center, Akron, Ohio. RECELL significantly reduced the mean number of pediatric grafting procedures compared to the National Burn Repository (1.6 treatments vs 3.6 treatments, respectively). One of the main goals within the burn community is to avoid multiple surgical grafting procedures. ![]() Unfortunately, nearly a quarter of the burn cases in the United States occur in children under the age of 16 years old. We look forward to continuing work under the contract, with the ongoing maintenance of the established vendor-managed inventory of RECELL System devices and collaboration toward enhancing the sustainability of the RECELL System as a mass casualty MCM and an improvement to everyday burn care in the United States,” says Dr. “BARDA and AVITA Medical have decided to stop recruitment for the ongoing pediatric burn study and follow currently enrolled patients for 12 months in alignment with the study protocol. As BARDA’s mandate includes building preparedness by expanding the indications of medical countermeasures (MCMs) for vulnerable populations, such as pediatrics, an independent contract option dedicated to this goal was exercised between BARDA and AVITA Medical in support of a pediatric burn clinical trial (NCT03626701). Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), under USG Contract HHSO100201500028C. The revised indication for the RECELL System is based on clinical data from the RECELL Compassionate Use (IDE 15945) and Continued Access (IDE 13053) studies, which were supported by the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. ![]() “Supported by a substantive body of clinical evidence and peer-review publications, the RECELL System is rapidly becoming the standard of care in burn treatment, and we are committed to pursuing and realizing the full potential of this innovative regenerative technology platform to address other clinical indications where significant unmet need exists.” Mike Perry, AVITA Medical’s Chief Executive Officer, in a news release. “We are pleased that the RECELL System, with both its clinical and health economic benefits, can now more broadly support surgeons in treating full-thickness burns of all sizes, including treatment of patients over 1-month of age,” says Dr. In addition, the indication now includes treatment for full-thickness thermal burns that extend beyond 50 percent total body surface area (TBSA). ![]() Specifically, RECELL is now indicated to treat full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age). Food and Drug Administration (FDA) approved expanded use of the RECELL System in combination with meshed autografting for the treatment of all sizes of acute full-thickness thermal burn wounds for both pediatric and adult patients. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |