Contura International, a medical technology company based in Denmark, reported the results of a five-year study of the long-term aesthetic results of Aquamid, which is used for facial soft tissue augmentation and facial contouring. The results were presented at the annual meeting of the American Society of Aesthetic Plastic Surgery in San Diego. Contura is currently conducting a multicenter, comparative clinical trial of Aquamid in the United States.
Aquamid, which was developed by Contura International, is used to rejuvenate or contour the face, either by restoring lost volume or by adding extra volume where needed.
The five-year study presented at the ASAPS meeting is a multicenter, prospective study of safety and long-term aesthetic results of Aquamid injections for facial soft tissue augmentation and facial contouring. A total of 116 patients attended the clinics for follow-up five years after their first Aquamid injection. The aesthetic outcome of injections with the Aquamid hydrogel showed that 96 percent of the 116 patients evaluated after five years had "very good"? or "good"? aesthetic results, according to the physician investigators, and 92 percent of the patients were "very satisfied"? or "satisfied."? The safety data in the trial showed that injection of Aquamid over a period of five years was safe with few and no unexpected adverse events. The five-year results are consistent with the data from the one-year, two-year and three- to four-year follow-up visits.
"We are excited that our European five-year clinical data demonstrates the long-term efficacy and safety of Aquamid,"? said Michael Peytz, chief executive officer of Contura International. "Aquamid is well positioned to meet the global consumer needs for long-lasting aesthetic treatments to restore facial volume. In 2008 we expect to complete the 12-month follow-up in our U.S. clinical trial and look forward to submitting the data to the FDA for review."?
Aquamid is composed of 97.5 percent sterile water and 2.5 percent cross-linked polyacrylamide. It is produced using Contura's patented hydrogel technology. The Aquamid hydrogel is homogenous and contains no microparticles, so its filling effect is due solely to the injected volume. Unlike particle-based fillers, the company says, the hydrogel does not rely on an intended foreign body reaction to achieve the desired augmentation. Therefore, the filling effect is immediate and predictable. Moreover, the hydrogel does not cause tissue hardening or fibrosis. No skin test is needed before treatment.
The company says the hydrogel integrates completely into the tissue and does not migrate from the injection site. It stays soft, feels like a natural part of the tissue and follows tissue movements. Because the hydrogel does not degrade over time, it provides augmentation that lasts for years.
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