ReCell Autologous Cell Harvesting Device - Autologous skin cell grafting kit

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Classe:

Class III

Prodotto da:

Avita Medical Americas LLC 28159 Avenue Stanford Suite 220, Valencia, CA, 91355 United States Of America

Area terapeutica:

58417 - Autologous skin cell grafting kit

Indicazioni terapeutiche:

A single-use, stand-alone, battery-operated, autologous cell harvesting device containing enzymatic and delivery solutions, sterile surgical instruments, and actuators. Enables thin split-thickness skin samples to be processed to produce a cell population for immediate delivery onto a prepared wound surface. The cell suspension contains a mixed population of cells obtained from the disaggregation of the skin sample inc melanocytes is important for restoring natural pigmentation to the recipient. ReCell is intended to be used to disaggregate cells from split-thickness skin samples and to collect these cells for reintroduction to the patient. These cells can be used as determined by a physician for: ? Treatment of partial-thickness tissue defects, including burns ? Reconstruction of scars to improve surface colour and texture ? Reconstructive surgery for epidermal defect (e.g., hypo-pigmentation, stable vitiligo)

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2020-07-03