FDA approves first commercial surgical glue for U.S.

In this story:

• 'Tisseel' made in Austria
• 'Super Glue' derivatives show promise

May 1, 1998
Web posted at: 5:59 p.m. EDT (2159 GMT)

WASHINGTON (CNN) -- The Food and Drug Administration on Friday approved the nation's first commercial surgical glue to help control bleeding during certain surgeries or trauma.

Tisseel, the brand name of the glue, is manufactured by Oesterreichisches Institut Fuer Haemoderivate GMBH in Vienna, Austria. It will be distributed in the United States by the Baxter Healthcare Corp., a California firm.

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 FDA approved the so-called fibrin sealant to be used in heart bypass surgery, colon surgery and in cases of traumatic spleen injury.

Fibrin sealants are applied topically during surgery to control bleeding from small, sometimes inaccessible blood vessels that are often difficult to seal and can be the source of uncontrolled bleeding.

Fibrin sealants clot and form a mesh over oozing blood vessels to slow down or stop bleeding.

The FDA says Tisseel helps control bleeding within five minutes.

'Super Glue' derivatives show promise

Although it is the first surgical glue to hit the U.S. market -- and it already has earned $50 million in Europe -- it's not the type of glue most U.S. doctors and patients are anticipating.

Other products, including a "Super Glue" derivative, are still awaiting FDA approval and promise to be heavier-duty alternatives to stitches or staples, which often leave scars, in everything from emergency-room wounds 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. That's 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 from 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 say what it would cost.

The Associated Press contributed to this report.

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• US Food and Drug Administration
  • Fibrin sealant
• Baxter Healthcare Corp.

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