First Tissue Adhesive for Internal Use Approved
The Food and Drug Administration (FDA) has approved Cohera Medical's TissuGlu Surgical Adhesive, the first tissue adhesive for internal use.
TissuGlu is a urethane-based adhesive connects tissue flaps made during abdominoplasty surgery. It is designed to close the "dead space" between tissue planes, which reduces the fluid accumulation in the wound cavity and potentially eliminates the need for surgical drains.
Once the drops of liquid TissuGlu are applied to the site, the water from the patient's tissue cures the adhesive, forming a cross-link with itself and the tissue surface. The cured adhesive degrades into absorbable subcomponents as the tissue heals over time.
The approval was based on a review of data from a study of 130 patients undergoing elective abdominoplasty. Half of the patients received TissuGlu with no drains, and the other half received surgical drains. Results showed that 73% of patients in the TissuGlu group did not require postoperative interventions to drain any accumulated fluid between the tissue flaps. Also, those who received TissuGlu without surgical drains were able to return to most daily activities sooner than those who had received surgical drains.
TissuGlu consists of a Multi-Tip Pivoting Head applicator that delivers measured droplets as well as a built-in spacer for even application. It does not require mixing and can be stored at room temperature.
For more information call (412) 231-1500 or visit CoheraMedical.com.