Device Dossier

Aliaxin SV - Superior Volume - Dermal tissue reconstructive material, microbe-derived

Device Dossier for Aliaxin SV - Superior Volume - Dermal tissue reconstructive material, microbe-derived (Dermal tissue reconstructive material,…

Intended purpose

Aliaxin® SV Superior Volume is a filling gel that is injected into the subcutaneous layer in order to restore volume in the required proportions. It is indicated for volume restoration and the filling of cutaneous depressions and wrinkles, and facial reconstruction of volumes in the event of light-to-moderate lipodystrophies, i.e. due to HIV treatment. Aliaxin® SV Superior Volume is indicated for the augmentation of cheeks, cheekbones and facial contours, as well as the filling of very deep wrinkles.

Functional description

Aliaxin SV is a biodegradable, sterile and non-pyrogenic viscoelastic hyaluronan hydrogel from non-animal origin. The single use pre-filled glass syringe is intended to be used to for the augmentation of cheeks, cheekbones and facial contours, as well as the filling of very deep wrinkles. The pack contains: 2 sterile pre-filled mono-use syringes of 1.1mL 2 pre-assembled plastic backstopes 2 27G needles - 13mm 2 27G needles - 19mm

TGA Public Summary