On 12 December, the ARTFiller range (synthetic-fluid tissue reconstructive material, anaesthetic), sponsored by Ebos Medical Devices Australia Pty Ltd, was added to the ARTG.
It was approved as a Medical Device Class III. It is a cross-linked hyaluronic acid-phosphate buffer gel injected under the skin to physically correct structural changes of the skin associated with ageing. It has a plumping/volume restoration effect to reduce facial wrinkles and skin folds, until degraded naturally by the body over several months. The lidocaine in the formulation acts as a short-term local anaesthetic for patient comfort during treatment. The pack contains two pre-filled syringes and four needles.
According to the TGA website, the ARTFiller range is intended to restore changes to skin structure caused by ageing: filling in lines and creases in the facial skin, and restoring volume. The VOLUME filler is indicated to restore volume to the mid-face, jawline and temples via subcutaneous, supraperiostal or deep dermis injections. ARTFiller UNIVERSAL filler is indicated to fill medium and deep naso-labial folds with or without marionette lines by injection into the middle to deep dermis and to increase the volume of the lip and enhance the lip outline. All fillers in the range contain Lidocaine to reduce any painful sensations for the patient during treatment. The complete range also includes FINE LINES, LIPS and LIPS SOFT.
According to artfiller.fillmed.com the ARTFiller collection was originally launched by Laboratoires FILLMED in 2016 and has been formulated with FILLMED’s TRI-HYAL technology, combining three types of hyaluronic acid and giving optimal malleability. The gels are made using non-animal origin hyaluronic acid and are highly malleable, making them designed for smoothing wrinkles, sculpting and adding volume.
In Australia, ARTFiller products will be distributed by Cryomed Aesthetics.
