Biodegradable Fibrin Sealant for Cardiovascular Surgery Use Approved
4/9/2010
The FDA has approved Nycomed Austria’s TachoSil, a ready-to-use biodegradable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels when standard surgical techniques are ineffective or impractical. TachoSil is composed of a dry collagen sponge made from horse tendons coated with fibrinogen and thrombin. The 2 proteins produce fibrin, a stringy, white, insoluble protein that allows clot formation, through a series of chemical reactions at the wound site. The TachoSil patch breaks down inside the body within 4 to 6 months and is not intended for use within blood vessels. The plasma used to manufacture TachoSil is collected from US donors who have been screened and tested for blood-transmitted diseases. The collagen derived from horse tendons and fibrinogen/thrombin used in the surgical patch has undergone additional manufacturing processes to remove impurities, including human bloodborne and equine viruses.