Contura has submitted a premarket approval application (PMA) for Aquamid to the FDA requesting marketing approval in the US for the aesthetic treatment of moderate to severe facial wrinkles and folds.
Contura said that the application includes a successful US pivotal study, in which the safety and efficacy of Aquamid was compared to Medicis’ Restylane for 12 months after treatment.
The study results were presented previous year at the American Society of Dermatologic Surgery’s Annual Meeting and at Plastic Surgery 2009, and showed that Aquamid was as effective as Restylane at 6 months follow-up based on the study endpoints and maintained this effectiveness at 12 months follow-up.
Contura said that the both treatments were safe and well tolerated. Also included in the application is a study extension that followed the Aquamid-treated subjects up to two years and demonstrated a consistent effectiveness and safety profile.
As per the company, if approved for the US market, Aquamid will be produced at Contura’s new manufacturing facility in Denmark, which was designed to meet FDA requirements, and was recently approved by the European authorities.
Aquamid is composed of 97.5% water for injection and 2.5% cross-linked polyacrylamide. The patented hydrogel is homogeneous: it contains no micro particles; hence its filling effect is due solely 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. Aquamid does not degrade over time and provides a choice for patients who are looking for a long lasting aesthetic solution.
Contura is a medical technology company based in Denmark that develops, manufactures, and commercializes soft tissue fillers in compliance with the European regulatory requirements for medical devices. Contura’s products Aquamid for facial contouring and Bulkamid for the treatment of female urinary incontinence are manufactured using the company’s patented polyacrylamide hydrogel technology.