The government approved the nation's first commercial surgical glue Friday, to help control bleeding during certain surgeries or trauma.
Baxter Healthcare Corp.'s Tisseel is made from two blood proteins, fibrinogen and thrombin, that naturally cause blood to clot when they latch together at the site of an injury.
The Food and Drug Administration approved the so-called fibrin sealant to be used in heart bypass surgery, colon surgery and in cases of traumatic spleen injury, all situations that can involve uncontrolled bleeding from small, hard-to-seal blood vessels.
Tisseel forms a flexible mesh over an oozing blood vessel to help control bleeding within five minutes, the FDA said.
Although Tisseel is the first surgical glue to reach the U.S. market _ and already earned $50-million in European sales last year _ it's not the type of glue most U.S. doctors and patients are anticipating. Other products, including a "Super Glue" derivative, still awaiting FDA approval promise to be heavier-duty alternatives to scar-prone stitches or staples in everything from emergency-room wound treatment to cosmetic surgery.
Surgical glues are sold in other countries, and U.S. doctors often bring some back from trips abroad or mix some up in private labs, which is legal as long as they use it on their own patients. Fibrin sealants make up the biggest proportion of this home-brew medicine, because they're easy to make from a patient's own blood or small amounts of donated blood. But many doctors have awaited an FDA-approved version, because the government oversight helps ensure each batch is safe and of the same quality.
Baxter will begin shipping Tisseel next week, but did not reveal a price.