Actamax announces presentation on 12 months clinical follow-up outcomes of novel sprayable adhesion barrier device
Adhesions are excessive scar tissue that forms between adjacent internal tissues. They are a consequence of normal wound healing and occur after 50-90% of surgeries. 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. Now, in the 12 months clinical follow-up study, results indicate that use of the Actamax adhesion barrier results in a reduction in symptomatology and an increased pregnancy rate. This outcome brings the medical community one step closer to meeting what is widely accepted amongst surgeons as a long-term unmet need - significant reduction in the prevalence and severity of adhesions in order to minimize patient suffering, promote healing and reduce complications.
Surgeon Geoffrey Trew (Hammersmith Hospital, London, UK), principal investigator for this study noted “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. 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.”
Marc Hendriks, President of Actamax stated, “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. 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.”
Actamax is in advanced stages to seek IDE approval and CE Mark registration for this device.
Surgery, trauma, infection and chronic inflammation (such as endometriosis) can elicit the formation of adhesions as part of the body’s normal healing response. A significant number of patients with adhesions develop complications ranging from discomfort, chronic pain and infertility (in women), to life-threatening complications such as small bowel obstruction. Post-surgical adhesions continue to be a significant concern, especially following intra-abdominal and pelvic surgery, and are now considered the most frequent complication in abdominopelvic surgery.
Surgeon Geoffrey Trew is presenting details of the study on 15 November at the 45th Global Congress on Minimally Invasive Gynecology to be held at the Rosen Hotel at Shingle Creek, Orlando, Florida.