FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery
Blood-clotting patch is absorbed by the body
The U.S. Food and Drug Administration today approved TachoSil, the
first 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.
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
“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,” said Karen Midthun, M.D., acting director of the FDA’s
Center for Biologics Evaluation and Research.
The plasma used to manufacture TachoSil is collected from U.S. 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 manufactured by Nycomed Austria GmbH of
Linz, Austria was evaluated in a study of 119 cardiovascular surgery
patients. Nearly three-quarters (74.6 percent) of those who received
TachoSil, stopped bleeding within three minutes compared with 33.3
percent 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.