MONDAY, April 5 (HealthDay News) -- The TachoSil sealant patch has been approved by the U.S. Food and Drug Administration to prevent bleeding from small blood vessels in certain cardiovascular surgery cases, the agency said Monday.
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The product is comprised of a collagen sponge, produced from horse tendons, that is coated with two proteins, fibrinogen and thrombin. The proteins trigger a series of chemical reactions that produce fibrin, a stringy protein that fosters production of a blood clot.
The biodegradable patch is designed to break down inside the body within six months. Plasma used in the product's manufacture is screened for blood-borne diseases, the FDA said, and the collagen taken from horse tendons is filtered from impurities, including viruses that affect horses.
In clinical testing involving 119 people, 74.6% of patch users stopped bleeding within three minutes, compared with 33.3% among those who didn't get the patch. Possible side effects include allergic reactions, the FDA said.
The product is manufactured by Nycomed Austria.
-- Scott Roberts
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