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Positive Data on Artefill Reported at Recent Conference
02/17/2010
Suneva Medical, a privately-held aesthetic medical device company, recently announced that Christopher B. Zachary, MBBS, FRCP, Professor and Chair, Department of Dermatology, University of California, Irvine, presented 18-month interim results from the prospective, open-label, 5-year safety and patient satisfaction study on Artefill for nasolabial fold (NLF) correction. The data were presented at the Skin Disease Education Foundation's 34th Annual "Hawaii Dermatology Seminar" in Waikoloa, Hawaii in February.
Dr. Zachary commented, "The safety data presented at the Hawaii Dermatology Seminar should give aesthetic physicians some long awaited encouragement to view Artefill on its merits as a safe and long-lasting dermal filler. My own experience with Artefill as both a clinical investigator in the open-label, long-term safety study, and as a commercial user has been very positive."
The 23-center, prospective, open-label study consists of 1,008 patients who had no recent history of nasolabial fold correction. According to a company press release, 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 at 2, 6, 12, 18, 24, 36, 48 and 60 months to assess the presence of or absence of adverse events, patient satisfaction, and any changes in health. Potential patient-reported adverse events 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.
Artefill is an FDA-approved microsphere-enhanced dermal filler for the correction of nasolabial fold. For more information visit www.artefill.com.