Exton PA, US, 21 Feb 2017 17:15 CET
Actamax Surgical Materials LLC, a wholly owned subsidiary of DSM Biomedical focusing on the development and commercialization of resorbable, biocompatible surgical medical devices that reduce the burden of post-operative complications, today announced that it has submitted an Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) to study the Actamax™ Adhesion Barrier in a prospective, randomized controlled trial in gynecological laparoscopic surgery. In pre-submission meetings, Actamax worked constructively with the FDA to discuss questions and concerns and has used FDA’s feedback to determine path forward for its IDE application.
"This IDE submission marks an important next step in advancing our Actamax Adhesion Barrier on the path to regulatory approval and commercialization," said Marc Hendriks, Ph.D., President of Actamax. "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.”
Surgery, trauma, infection and chronic inflammation (such as endometriosis) can elicit the formation of adhesions as part of the body’s normal healing response. Adhesions are excessive scar tissue that forms between adjacent internal tissues. A significant number of patients with adhesions develop complications ranging from discomfort, chronic pain and infertility (in women), to life-threatening consequences such as small bowel obstruction.
Previously, the safety, efficacy, and ease of use of the Actamax Adhesion Barrier was demonstrated in a 78-patient, multi-center clinical study in women undergoing a variety of gynecological surgeries. In the ensuing 12 month clinical follow-up of 47 study patients, there was evidence suggestive of improved long-term outcomes, including a lower recurrence rate of pre-study symptoms, and a higher probability of pregnancy in patients with whom the Actamax Adhesion Barrier was used.