Nycomed and Baxter receive FDA approval to market TachoSil in the USA

Swiss drugmaker Nycomed and its partner, USA-based Baxter International, have received the approval for TachoSil, a surgical patch, from the US Food and Drug Administration. TachoSil has been approved as an adjunct to hemostasis (control of bleeding) in cardiovascular surgery.

This is the key product in Nycomed's tissue management portfolio and fulfils the market need for a ready-to-use surgical patch, developed to assist surgeons in achieving fast and reliable bleeding control. With the US approval, Nycomed and Baxter can offer the surgical patch for use as an adjunct to hemostasis in cardiovascular surgery.

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.