The FDA has approved Nycomed Austria GmbH’s TachoSil, an absorbable sealant patch designed to prevent bleeding from small blood vessels after cardiovascular surgery. The patch is composed of collagen from horse tendons, and coated with fibrinogen and thrombin which are extracted from donated human plasma. When applied to the wound site, the thrombin and fibrinogen combine to form fibrin monomers, and endogenous factor XIII facilitates the cross-linking of these monomers, forming an air- and liquid-tight seal.
From the press release:
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.
The effectiveness of TachoSil 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.
Press release: FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery…
Product page: TachoSil…
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