Actamax Surgical Materials, a DSM-DuPont joint venture, said today that it submitted an Investigational Device Exemption application to the FDA for its adhesion barrier device in gynecological laparoscopic surgery.
Adhesions, excessive scar tissue that can form between adjacent internal tissues, are a result of normal wound healing. Adhesions occur post-surgical operations at rates of 50-90%.
A previous clinical study with 78 patients showed the safety and efficacy of Actamax’s adhesion barrier with women undergoing gynecological surgery.
The Berkeley, Calif.-based company said it worked constructively with the FDA in pre-submission meetings to discuss questions and concerns about the IDE application.
“This IDE submission marks an important next step in advancing our Actamax Adhesion Barrier on the path to regulatory approval and commercialization,” president Marc Hendriks said in prepared remarks. “Previously obtained results from both the First-in-Human trial and the ensuing 12 months, long-term follow-up on the use of this adhesion barrier product are very promising. We believe that the data we are submitting to the FDA supports the safety and efficacy of the Actamax Adhesion Barrier. The proposed pivotal study in a larger population will help clarify the product’s place in the area of abdominopelvic surgery, where post-surgical adhesions are considered the most frequent complication.”
In November last year, Actamax touted data from a 12-month clinical follow-up study evaluating the effects of its biocompatible, resorbable adhesion barrier device. The results showed that using its device reduces symptomatology and increases pregnancy rates among patients.
The company also said it is seeking CE Mark registration for the device.