Cohesion Technologies Inc has received CE Mark approval for Adhibit adhesion prevention gel, to prevent or reduce the incidence, severity and extent of post surgical adhesion formation in patients undergoing cardiac surgery.
Adhibit is a completely synthetic, self-polymerizing liquid hydrogel that is safely metabolized by the body in less than 30 days. In addition, Adhibit is quick to prepare -- about 1 minute -- easily applied with a spray system, and, importantly, adheres to the tissue where it is applied, and remains in place during the critical wound-healing period, when adhesions typically form.
Adhesions are scar tissues caused by trauma or surgery, which connect organs or tissue surfaces that are normally separate. Adhesions can be life threatening by making surgical re-entry hazardous, impeding orientation and visibility. Dissecting adhesions may cause injury to surrounding organs or blood vessels, increase blood loss and prolong operating time.
Adhesions often cause severe pain, discomfort, limited range of motion and organ dysfunction. In an effort to relieve pain or free an obstruction caused by adhesions, additional surgeries may be required to dissect the adhesions. As an example, adhesions are a leading cause of infertility in women following gynecological surgery.
Prophylactic use of Adhibit could result in significant benefits to patients, physicians and the health care system.
Adhibit is based on the same chemistry as CoSeal surgical sealant, Cohesion Technologies' product approved for use in the U.S., Canada, Australia and Europe as a vascular sealant. Adhibit will be marketed under the Adhibit adhesion prevention gel trade name and will be packaged with delivery systems specifically designed for adhesion prevention applications. Adhibit is not approved for use in the U.S. Cohesion expects to file an IDE with the U.S. Food and Drug Administration by early 2003 seeking consent to begin a U.S. clinical study with Adhibit for the prevention of post-surgical adhesions.