Suneva Medical, an aesthetic medical device company, has presented interim results from the prospective, open-label, five-year safety study on Artefill for nasolabial fold (NLF) correction.
Suneva Medical said that the oral presentations took place at the American Society of Aesthetic Plastic Surgery’s Aesthetic Meeting 2010 in Washington, DC and the American Academy of Facial Plastic & Reconstructive Surgery’s International Symposium in Hollywood, FL, respectively.
According to Suneva Medical, the 23-center, prospective, open-label study consists of 1,008 patients who had no recent history of nasolabial fold correction. 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 subject-reported adverse events (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.
Steven Cohen, clinical professor at University of California, said: “Artefill has consistently proven to be an effective, more permanent treatment option for smile lines. Our initial findings from this five-year study are consistent with the pivotal trial and show Artefill has a safety profile that appears to be similar to other dermal fillers on the market today.”
John Joseph, assistant clinical professor at UCLA, said: “Patient satisfaction is critical to our success as surgeons. Our patients have been extremely pleased with the long-term benefits of Artefill and the interim trial results further support this, showing consistent and lasting high patient satisfaction ratings with the product.”