FDA approves first internal-use tissue glue
FDA approved TissuGlu (Cohera Medical Inc.), the first tissue adhesive approved for internal use.
FDA approved TissuGlu (Cohera Medical Inc.), the first tissue adhesive approved for internal use.
TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during abdominoplasty surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles.
“Connecting the tissue flaps with an internal adhesive may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps,” according to a statement from FDA.
“The FDA’s approval of the first synthetic adhesive for internal use will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” said William Maisel, MD, MPH, deputy director for science at FDA’s Center for Devices and Radiological Health, in a statement.
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FDA’s review of TissuGlu included data from a clinical study of 130 participants undergoing elective abdominoplasty. Half of the participants received surgical drains while the other half received TissuGlu and no drains.
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The study results showed that 73% of participants who received TissuGlu required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps. Those who did require intervention, however, were more likely to require another operation to insert surgical drains.
Participants who received TissuGlu without surgical drains were generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains. There was no difference between the two groups in reported levels of pain or discomfort due to the surgery.
