Artefill Safety Information
Artefill is a safe and effective dermal filler for the correction of nasolabial folds.
- The microsphere-enhanced collagen technology has been optimized over several generations contributing to less adverse events when compared to older PMMA-based fillers 1,2
- Over 25,000 patients have been treated with Artefill since its US Launch in February 2007
- There have been no product recalls and no substantiated medical device reports to date for Artefill
US pivotal prospective and open-label clinical trials
In the US pivotal prospective and open-label clinical trials, the safety profile of the second-generation PMMA filler Artecoll® was similar to the temporary filler control 1,3 The data from the pivotal study formed the basis for the approval of the current day third-generation product Artefill.
Five-Year Prospective Study
Currently, a prospective 5-year study of 1,008 patients is being conducted by 23 institutions to evaluate the long term safety of the current Artefill formulation. The study was initiated in October 2007 and is now completely enrolled. The five-year study is being conducted to follow the long term safety of Artefill for the correction of nasolabial folds.
1 Carruthers J, Cohen S, Joseph J, Narins R, Rubin M. The Science and Art of Dermal Fillers for Soft-Tissue Augmentation. J Drugs in Derm. 2009; 8(4)
2 Hilinski J, Cohen S. Soft Tissue Augmentation with Artefill. Facial Plastic Surgery. 2009; 25(2)
3 Artefill Instructions for Use. San Diego, CA: Suneva Medical, Inc.; 2009