Ethicon, Inc. said the US Food and Drug Administration have granted an expanded indication for Evicel Fibrin Sealant (Human). The product is the first fibrin sealant to be indicated as an adjunct to haemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical.
Evicel is manufactured by Omrix Biopharmaceuticals and is distributed by Johnson & Johnson Wound Management, a division of Ethicon, Inc.
"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, Albany Medical Center. "Evicel has become an important element of haemostasis 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. No adverse events of this type were reported during the conduction of the clinical trials, the company said.
Evicel is the only all-human plasma-derived fibrin sealant commercially available in the US. It does not contain aprotinin, which has been associated with adverse health effects. Evicel is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing.
Ethicon, Inc., a Johnson & Johnson company, is a global medical device company that develops and markets surgical products for use in general surgery, wound management and women's health and urology.