TachoSil Sealant Patch Approved for Cardiovascular Surgery
MONDAY April 5, 2010 -- 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.
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 percent of patch users stopped bleeding within three minutes, compared with 33.3 percent among those who didn't get the patch. Possible side effects include allergic reactions, the FDA said.
The product is manufactured by Nycomed Austria.
The FDA has more about this approval.
Posted: April 2010