FDA Approves New Protocol for the ReCell Device for Treatment of Burn Injuries
Avita Medical received FDA approval for a supplement to the company’s investigational device exemption for its ReCell autologous cell harvesting device. The approved protocol for treatment of burn injuries has been simplified from the previously-approved continued access protocol and the number of approved investigational sites has increased from 8 to 15.
To date, treatment of patients with the ReCell device under continued access was done according to a complex protocol requiring a randomized comparison between two distinct areas of burn injury, with one area treated using conventional skin grafts and one area treated with more expanded autografts applied in combination with regenerative epithelial suspension (RES) from the ReCell device.
The newly approved protocol allows for the use of RES with expanded (meshed) autografts without requiring the randomized comparison to a conventional graft. This change simplifies the protocol more straightforward for burn teams and patients.