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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
FDA approves first tissue adhesive for internal use

On 4 February 2015, the U.S. Food and Drug Administration (FDA) today approved TissuGlu, 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 surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles (abdominoplasty surgery). 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.  

Drops of liquid TissuGlu are applied by a surgeon using a hand-held applicator. After applying the drops, the surgeon positions the abdominoplasty flap in place. Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures.

“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, M.D., M.P.H., deputy director for science at FDA’s Center for Devices and Radiological Health.

The 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. The study results showed that 73 percent of participants who received TissuGlu required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps.

In the 27% of patients who did require invasive treatments, 21% received needle aspirations alone. Six percent of the TissuGlu group received both needle aspirations and drains for persistent seroma formation.

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.

TissuGlu is manufactured by Cohera Medical, Inc., located in Pittsburgh, Pennsylvania.