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FDA Clears Biodegradable Sealant Patch For Cardiovascular Surgery

FDA has approved TachoSil, an absorbable 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.

Manufactured by Nycomed Austria of Linz, TachoSil is a ready-to-use surgical patch composed of a dry collagen sponge made from horse tendons, and coated with fibrinogen and thrombin. At the site of a wound, the two proteins, through a series of chemical reactions, produce fibrin, a stringy, white, insoluble protein that allows a clot to form.

The TachoSil patch is biodegradable and breaks down inside the body within four to six months. TachoSil is not intended for use within blood vessels.

Nycomed said that the plasma used to manufacture TachoSil is collected from US donors who have been screened and tested for diseases transmitted by blood. The fibrinogen and thrombin used in the surgical patch undergo additional manufacturing processes to remove impurities, including bloodborne viruses. The collagen taken from horse tendons undergoes a separate step to remove impurities, including equine viruses.

The effectiveness of TachoSil was evaluated in a study of 119 cardiovascular surgery patients. Nearly three-quarters (74.6%) of those who received TachoSil, stopped bleeding within three minutes compared with 33.3% in the control group.

Hypersensitivity to product components or allergic reactions may occur with TachoSil. The adverse reaction rates were not statistically different between the study and control groups.

Karen Midthun, acting director of the Center for Biologics Evaluation and Research at FDA, said: “This approval provides an additional tool for surgeons to help control mild and moderate bleeding from blood vessels during cardiovascular surgery when standard surgical techniques are ineffective or impractical.”