FDAnews
www.fdanews.com/articles/169837-fda-approves-first-tissue-adhesive-for-internal-use

FDA Approves First Tissue Adhesive for Internal Use

February 4, 2015

The FDA on Wednesday approved Cohera Medical’s TissuGlu for use in abdominoplasties — the first tissue adhesive approved for internal use.

The urethane-based adhesive is used during tummy tuck procedures to connect the flaps used to remove excess fat and skin or restore weakened or separated abdominal muscles. Connecting these tissue flaps with an internal adhesive can reduce or eliminate the need for postoperative draining of fluid between the flaps, the agency said.

After TissuGlu is applied to the flaps, water in the tissue causes a chemical reaction, bonding the flaps together, according to the FDA. The surgeon then closes the skin using sutures.

Cohera tested the glue in 130 abdominoplasty patients. Half received surgical drains while the other half got TissuGlu. Of those in the TissuGlu arm, 73 percent required no fluid draining procedures, the FDA said. Patients with TissuGlu also were able to resume daily activities sooner.

No difference in pain or discomfort was reported for the two treatment arms. — Kellen Owings