January 10, 2008 – The FDA today granted Ethicon Inc. an expanded indication for EVICEL Fibrin Sealant (Human), which is one of the first fibrin sealants available as an adjunct to hemostasis for use in surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.
EVICEL is an all-human, plasma-derived fibrin. It does not contain aprotinin, which has been associated with adverse health effects. The product is sold as a frozen liquid and requires less than one-minute preparation time after thawing.
“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. “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. Anaphylactic reactions may occur. The company said no adverse events of this type were reported during the conduction of the clinical trials.
For more information: www.ethicon.com