Cohera Medical, Inc., a company spun out of the University of Pittsburgh, has gained the U.S. Food and Drug Administration go-ahead to market TissuGlu, the first surgical tissue adhesive for internal use during abdominoplasty (tummy tuck) surgery.
Developed by Pitt chemical engineering professor Eric Beckman and oral and maxillofacial surgeon Michael Buckley (formerly of Pitt’s School of Dental Medicine), the biodegradable, biocompatible product provides surgeons with an alternative to stapling, stitching or less effective surgical wound sealants used to connect tissue flaps during abdominoplasty surgery, according to the FDA website.
And the use of TissuGlu may also reduce or eliminate the need for uncomfortable postoperative surgical drains and offer other advantages, including lowering the risk of postoperative complications that could occur from drain use, says Beckman.
“The FDA’s approval of the first synthetic adhesive for internal use will help some abdominoplasty patients get back to their daily routines after surgery more quickly than if surgical drains had been inserted,” says William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health.
In a clinical study of 130 patients undergoing elective abdominoplasty, half received surgical drains and the other half received TissuGlu with no drains. Seventy-three percent of those who received TissuGlu required no postoperative intervention to drain fluid.
TissuGlu is a urethane-based liquid, applied by surgeons using a hand-held applicator—or the “world’s coolest glue gun,” as Beckman refers to it—and is dispensed into the patient’s tissue during surgery.
“We wanted something that was easy, quick and obvious. It takes a surgeon about two minutes to learn to use,” says Beckman.
Tissue flaps are bonded together when water in the tissue triggers chemical reactions that cure the adhesive into a flexible solid. Unlike topical medical super glues that take 30 seconds to cure, TissuGlu takes about 10 minutes to form into a flexible solid.
“Clinicians have lacked internal adhesives that are both strong and safe, and it’s exciting that TissuGlu is the first internal tissue adhesive to be approved by the FDA,” says Beckman.
He adds that TissuGlu is so new that the FDA created a category for the product’s approval and that premarket approval (PMA) from the FDA is rare.
“It’s normally a long process to go through the FDA and can easily take 10 to 12 years,” says Beckman.
After completing European clinical trials in 2010 and receiving a CE mark certifying conformity with European Union health standards in July 2011, Cohera launched TissuGlu that same year in Germany.
Marketing details are still being ironed out, says Beckman, and it will probably be “a few months” before TissuGlu is available.