A Medical Device Daily
Artes Medical (San Diego) said enrollment has been completed in the 1,000-patient post-marketing study required by the FDA. The study follows patients treated with ArteFill, the company's non-resorbable dermal filler, for a five-year period.
Artes reported that study participants have now been screened and entered into the study which includes a skin test, ArteFill injections and follow-up evaluations for safety and duration of treatment effects of their facial wrinkles, known as nasolabial folds or smile lines. An ArteFill skin test is required before initial treatment.
The most common adverse events associated with ArteFill treatment, similar to those observed with other dermal fillers, are lumpiness, persistent swelling or redness and increased sensitivity at the injection site.
ArteFill is a formulation comprised of polymethylmethacrylate, or PMMA, microspheres and bovine collagen, and is the only PMMA-based injectable product that has been approved by the FDA for the treatment of facial wrinkles. Artes Medical is the sole manufacturer of ArteFill.