Artes Medical announced that the US  Food and Drug Administration has approved ArteFill® for the correction of facial wrinkles. Unlike existing dermal fillers that are metabolized by the body, ArteFill is nonresorbable and provides a support structure for wrinkle correction.

ArteFill contains a proprietary combination of “precision-filtered microspheres” that are suspended in a carrier gel containing purified bovine collagen. Artes produces the microspheres from a commonly-used synthetic implant material in medicine, poly(methyl methacrylate).

The size of the microspheres is regulated to ensure consistent and safe results. The microspheres are 30 to 50 micrometers in diameter, barely visible to the naked eye. After ArteFill is injected into a patient’s smile line, the microspheres provide a permanent support structure beneath the skin to support the wrinkle and to prevent further wrinkling.

An ArteFill skin test is required before initial treatment. Common side effects include lumpiness, persistent swelling, and redness and increased sensitivity at the injection site.

[www.engelpub.com, October 30, 2006]