Integra Meshed Dermal Regeneration Template - Skin regeneration template, human-/animal-derived

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Integra Neurosciences Pty Ltd

Class:

Class III

Manufactured by:

Integra Lifesciences Corporation 1100 Campus Road, Princeton, New Jersey, 08540 United States Of America

Therapeutic area:

46170 - Skin regeneration template, human-/animal-derived

Therapeutic indications:

A bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. It is indicated for the post excisional treatment of full-thickness and partial-thickness injuries where sufficient auto graft is not available at the time of excision or not desirable due to the physiological condition of the patient. INTEGRA Dermal Regeneration Template is also indicated for use in reconstruction of post excisional, full-thickness defects of the integument where there is, in the opinion of the treating surgeon, a potential benefit to the patient by improving the reconstructive outcome or decreasing their mortality/morbidity.

Authorization status:

A

Authorization date:

2021-12-24