Parsippany NJ, US, 20 Sep 2017 18:30 CEST
Actamax Surgical Materials LLC, a wholly owned subsidiary of DSM, focused on design of bioresorbable medical devices to reduce the burden of post-operative complications for patients undergoing surgery, announced it has received conditional approval of an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). This approval allows Actamax to begin a pivotal clinical trial to evaluate the safety and efficacy of Actamax™ Adhesion Barrier.
Adhesion formation occurs as part of the body’s healing response to surgery, trauma, infection and chronic inflammation (such as endometriosis). Adhesions are excessive scar tissue that forms between adjacent internal tissues and may cause complications such as discomfort, chronic pain, female infertility, small bowel obstruction, and some cases may require reoperation.
"There has long been a need in the market for advances in medical technology to address adhesive disease. Adhesions continue to be a major cause of complications and morbidity in postoperative patients undergoing routine abdominal-pelvic surgery. This novel technology, an easy to use sprayable barrier device, has a promising future in preventing the formation of adhesions”, noted surgeon Geoffrey Trew (Hammersmith Hospital, London, UK), principal investigator for the pivotal clinical trial.
"We are pleased to have reached this initial milestone, further advancing our Actamax Adhesion Barrier on the path to market approval and commercialization", stated Marc Hendriks, PhD, President of Actamax. “Subject to study registrations and Institutional Review Board approvals, we expect to commence the evaluation of the Actamax Adhesion Barrier in a prospective, randomized controlled trial in gynecological laparoscopic surgery in clinical centers in the US and Europe in the second quarter of 2018.”
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 months 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 treated with the Actamax Adhesion Barrier.