Avita Medical Reports Results of RECELL System in Investigational Device Exemption (IDE) Compassionate Use and Continued Access Studies for Third-Degree Burns in Pediatric Patients
Shots:
- The IDE compassionate use and continued access studies involve assessing of Spray-On Skin Cells prepared using the RECELL system + meshed autografts in 107 pediatric patients with deep burn injuries
- The interim analyses results: healing within 4wks. (98%); patients with >50% TBSA achieve the same rate of healing as patients with ≤50% TBSA; donor sites healed within a wk. & 2wks. (62.5% & 100%); Presented at the American Burn Association (ABA)
- The RECELL system is an autologous cell harvesting device utilizes the patient’s own skin to produce a suspension of Spray-On Skin Cells in 30mins. for the treatment of thermal burns. In Sept’18- it has received FDA’s approval for acute thermal burns in patients ≥ 18yrs. with TGA registration in Australia & CFDA clearance in China
Ref: Avita Medical | Image: MedGadget
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