FDA Advisory Committee recommends TissueGlu adhesive for surgical procedures - Cohera Medical

The FDA General and Plastic Surgery Advisory Committee has voted unanimously that TissuGlu Surgical Adhesive from Cohera Medical is safe. 6-5 members voted that it is effective and 6-4 members voted (with one abstention) that it has a favourable risk-benefit profile.

The TissuGlu adhesive is delivered via a handheld applicator that contains 5 milliliters of the adhesive. The proposed indication is for "the approximation of tissue layers" in large-flap surgical procedures such as abdominoplasty (tummy tuck surgery).

TissuGlu is an internal adhesive designed to stick to tissue flaps during surgery, working to reduce the buildup of fluids that can accumulate while patients heal and cut back the need for postoperative drains. The use of drains is a huge detriment to patient comfort and can forestall healing times, suggesting that the innovative TissuGlu serves a large unmet need.

TissuGlu has CE mark approval since 2011.