FDA Approves Biodegradable Sealant Patch For Cardiovascular Surgery

This is one item you are supposed to leave inside instead of having to remove. The collagen in the patch comes from horses tendons. The whole idea here is to cut down bleeding during cardiovascular surgery.

It rolls up and goes into the endoscope for minimally invasive procedures as well. It can be used for other types of surgeries as well, such as spleen surgery, ovarian surgery and surgery for rectal cancer. BD

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 impuri ties, including bloodborne viruses. The collagen taken from horse tendons undergoes a separate step to remove impurities, including equine viruses.