Actamax Surgical Materials, a DSM-DuPont joint venture, touted data from a 12-month clinical follow-up study evaluating the effects of its biocompatible, resorbable adhesion barrier device. The results were presented this week at the 45th Global Congress on Minimally Invasive Gynecology in Orlando, Fla.
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 that the 12 month clinical follow-up study showed that using its adhesion barrier reduces symptomatology and increases pregnancy rates among patients. Actamax also reported that it is seeking IDE approval and CE Mark registration for the adhesion barrier device.
“The clinical community is in strong need of products that prevent new adhesions as well as their reformation. Adhesions are a clinical problem in both open and keyhole surgeries,” principal investigator Dr. Geoffrey Trew said in prepared remarks. “The results from this 12 months, long-term follow-up clinical study of this adhesion barrier product are very promising and encouraging. Further investigation with a larger population will help clarify the product’s place in this challenging area which has been a significant concern of surgeons for decades.”
“We are excited about these positive long-term follow up results on our product. These results confirm that we are on the right track to deliver a long awaited innovative solution that minimizes patient discomfort and complications following surgery,” president Marc Hendriks added. “This surgical specialty product perfectly positions Actamax in today’s medical technology market that requires companies to come up with solutions that can reduce overall cost of care.”