Cohera Medical Inc®’s TissuGlu® should be approved for use in large flap surgeries such as abdominoplasties, according to a US Food and Drug Administration advisory panel.
The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted favorably that TissuGlu is safe and effective, and that the benefits outweigh the risks.
The FDA is not obligated to follow the advice of its advisory arms, but it usually does.
If approved, TissuGlu may be an alternative to closed suction drains in large flap procedures, potentially reducing the number of postoperative procedures and improving patient recovery.
TissuGlu adheres the tissue flap created during the procedure to the underlying tissue to reduce the fluid that can accumulate in the space during healing.
TissuGlu has received CE Marking approval to be sold in the European Union.