A new surgical adhesion barrier to prevent post-operative adhesions in the abdominal or pelvic area has gained CE Mark approval.
CollaGUARD from US surgical implant specialist Innocoll will be launched in the EU this year through a network of distributors. The company also plans to seek worldwide approval for the device.
A transparent bioresorbable collagen film developed using Innocoll’s proprietary technology, CollaGUARD is approved in Europe for the prevention of postoperative adhesions in patients undergoing minimally-invasive pelvic or abdominal surgery.
The device is implanted through a trocar at the time of surgery as a temporary barrier to separate apposing potentially adhesive surfaces during tissue repair.
In vivo tests have shown that CollaGUARD increases the probability of the surgical site remaining adhesion-free by a factor of 6 or more.
CollaGUARD is stable at room temperature, non-tacky and easily handled; it can be rolled, cut and sutured, making it suitable for a broad range of surgical procedures.
Postoperative adhesions (fibrous growths between surfaces) are common in surgical procedures and can lead to serious complications such as obstruction, chronic pain and secondary female infertility, as well as interfering with later surgery.
Dr. Michael Myers, President and CEO of Innacoll, said: “EU registration for CollaGUARD represents an important milestone for Innocoll. This is the first significant approval for a product developed using our proprietary CollaFilm technology and we are on track to launch this year.”
Referring to other products nearing commercial launch, he added: “Innocoll is assembling an exciting portfolio of late-stage assets.”
Based in Virginia, Innocoll specialises in biodegradable surgical implants and topically applied healthcare products derived from its collagen technologies.