SAN DIEGO, CA – May 5, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced the publication of interim results from its long-term study on ArteFill in the May 2010 issue of Dermatologic Surgery, the Journal of the American Society of Dermatologic Surgery. The study highlights the safety profile (adverse events, granuloma incidence) and level of patient satisfaction with ArteFill for nasolabial fold (NLF) correction 18-months into the 5-year follow-up period.
Steven R. Cohen, M.D., F.A.C.S, Clinical Professor, University of California, San Diego, CA and co-author commented, “Our findings further substantiate the safety of this PMMA microsphere dermal filler and we hope will alleviate some of the misperceptions in the market about its long-term safety profile.”
This open-label, prospective, post-approval study is being conducted at 23 centers in the United States. Subjects seeking treatment with the injectable filler for the correction of nasolabial folds were recruited and 1,008 patients with no recent history of nasolabial fold correction were enrolled. Patients received an initial treatment with Artefill, and up to two touch-ups after 30 and 60 days, until full correction was achieved. Potential adverse events and satisfaction data are reported by all patients 6, 12, 18, 24, 36, 48 and 60 months by questionnaire to assess the presence of or absence of adverse events, patient satisfaction, and any changes in health. Potential subject-reported AEs were followed up on and changes thought to be granulomas were biopsied and confirmed or ruled out by histology. All study patients will complete a final in-office visit at 60-months.
These initial results show the incidence of adverse events with Artefill compare favorably to the current label and are similar to the safety profile seen in temporary fillers. Overall, 6% percent (49/1008) of subjects experienced device related adverse events, however, the majority were mild and none were unanticipated. There were no device related serious adverse events reported. One granuloma was reported, which resolved completely with medical treatment. Patient satisfaction with Artefill remained high (~80% very satisfied/satisfied) throughout the entire follow-up period.
Artefill is the first and only FDA-approved microsphere-enhanced dermal filler for the correction of nasolabial folds, better known as smile lines. Since Artefill was approved in 2006, over 20,000 patients have been treated. For more information visit www.artefill.com.
About Suneva Medical
Suneva Medical, Inc. is a medical technology company focused on developing, manufacturing and commercializing novel, differentiated aesthetic products for the dermatology, plastic and cosmetic surgery markets. The Company’s lead product is Artefill®, the first and only microsphere-enhanced dermal filler for the correction of nasolabial folds, or smile lines. For more information visit www.sunevamedical.com/old.