Contura International A/S announces that 5-year clinical data for its soft volume filler Aquamid(R) was presented at the recent American Society of Aesthetic Plastic Surgery (ASAPS) annual meeting in San Diego. Aquamid is used to rejuvenate or contour the face by restoring lost volume or by adding volume where needed.
The study included 116 patients who attended the clinics for follow-up 5 years after their first Aquamid injection. The results showed that 96% of the 116 patients had "very good" or "good" aesthetic results, according to the physician investigators, and 92% of the patients were "very satisfied" or "satisfied." The safety data in the trial showed that injection of Aquamid over a period of 5 years was safe with few and no unexpected adverse events. The results are consistent with the data from the 1st-year, 2nd-year, 3th, and 4th year follow-up visits.
"We are excited that our European 5-year clinical data demonstrates the long-term efficacy and safety of Aquamid," says Michael Peytz, CEO at Contura International A/S. "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 US clinical trial and look forward to submitting the data to the FDA for review."
According to the company, Aquamid is composed of 97.5% sterile water and 2.5% cross-linked polyacrylamide. The Aquamid hydrogel is homogeneous. It contains no microparticles. Its filling effect is due to the injected volume. Unlike particle-based fillers, the hydrogel does not rely on an intended foreign body reaction to achieve the desired augmentation. Therefore, the filling effect is immediate and predictable. The hydrogel does not cause tissue hardening or fibrosis. No skin test is needed before treatment.
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.
Aquamid is available in 40 countries worldwide and is under clinical investigation in the United States.
[Medical News Today, May 6, 2008]