The U.S. Food and Drug Administration on Wednesday approved the first tissue adhesive for internal use in the body, giving a big boost to the Pittsburgh company that has spent eight years developing its first product.
TissuGlu, made by Cohera Medical Inc., is a nontoxic version of urethane, the versatile polymer used to make plastics. Surgeons can use it to reconnect the big sheets of tissue created during abdominoplasties, or "tummy tucks," in which excess fat and skin are cut away.
The adhesive reduces internal dead space where fluid builds up, reducing or eliminating the need for postoperative surgical drains.
In the United States, about 175,000 tummy tucks will be done this year, and that number is growing by almost 8 percent annually, according to Cohera.
FDA approval "is truly a significant milestone for the company," president and CEO Patrick Daly said.
The approval "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, a top FDA device regulator. TissuGlu was discovered by University of Pittsburgh polymer chemist Eric Beckman. Surgeons apply drops of the compound using a special handheld applicator; then, water in the tissue triggers a chemical reaction that bonds the tissue flaps together. The skin is closed using traditional sutures. After the tissue flaps heal, the biocompatible adhesive breaks down and the body eliminates it.
The FDA reviewed a Cohera study of 130 tummy-tuck patients. Half received standard surgical drains, and the other half received TissuGlu and no drains.
All patients with drains needed the devices for seven to 10 days. In contrast, 73 percent of glued patients required no drains; the rest had small amounts of fluid aspirated with a needle.
Daly said TissuGlu fit with efforts to make surgeries less invasive and speed patient recovery. A spokesman said the U.S. price had not been set.
In Europe, where the product was approved in 2011, it is used for mastectomies as well as tummy tucks. Daly said Cohera planned to seek FDA approval for additional uses. The company also has a pipeline of products, including a sealant for leaky surgical connections, and a foam designed to arrest bleeding.
Although TissuGlu is the first glue approved for internal use, medical adhesives are a well-established, growing field. Analysts have valued the global market for products that glue or seal skin, eyes, bones, and blood vessels at more than $3.1 billion. Cyanoacrylate - the compound in Krazy Glue - is now a standard treatment for skin cuts in emergency rooms, and is sold over the counter as "liquid bandages."