Human Fibrin Sealant Approved for General Surgical Hemostasis

A human fibrin sealant has been approved by the U.S. Food and Drug Administration (FDA) as an adjunct to hemostasis in patients undergoing general surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.

Evicel, a human-plasma-based product, is supplied as a kit consisting of two separate packages, each containing one vial of Biologically Active Component 2 (BAC2, 55-85 mg/ml fibrinogen) and one vial of thrombin (800-1200 IU/ml human thrombin) frozen solutions. The product is easy to use and readily available for time-sensitive needs in the operating room (OR). The frozen solutions require less than one-minute preparation time after thawing; unused contents should be discarded. The sealant should be applied on the surface of bleeding tissue only, either sprayed or dripped onto the tissue in short bursts (0.1-0.2 ml) to produce a thin, even layer. If the hemostatic effect is not complete, a second layer should be applied. Evicel is manufactured by Omrix Biopharmaceuticals (New York, NY, USA) and is distributed by Ethicon (Somerville, NJ, USA).

"In surgery, the success of the procedure can sometimes depend upon the surgeon's ability to control blood loss quickly and effectively,” said R. Clement Darling III, M.D., head of the division of vascular surgery at Albany Medical Center (NY, USA). "EVICEL has become an important element of hemostasis in many liver and vascular procedures. The expansion of its indication to general surgery will bring the benefits of this product to more surgeons and their patients.”

Evicel is contraindicated in individuals known to have anaphylactic or severe systemic reaction to human blood products; as with all plasma-derived products, the risk of transmitting infectious agents cannot be completely eliminated. Evicel should not be injected directly into the circulatory system or used for the treatment of severe or brisk arterial bleeding.


Related Links:
Omrix Biopharmaceuticals
Ethicon