FDA Expands Use of Evicel for General Surgical Bleeding Control

By Anna Boyd
13:36, January 18th 2008
94 votes
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FDA Expands Use of Evicel for General Surgical Bleeding Control

The U.S. Food and Drug Administration has reportedly expanded the use of a liquid protein sealant called Evicel, which help control bleeding during surgical procedures, to include all general surgeries.

Evicel, manufactured by OMRIX Biopharmaceuticals LTD of Kiryat Ono, Israel, is a liquid fibrin sealant, which is sprayed or dripped onto small, oozing blood vessels to help stop bleeding. Originally, the sealant was approved five years ago under the name Crosseal for use during liver surgery. In May 2007, it became Evicel and it was approved for vascular surgery. Now the FDA decided to expand its use to cover all general surgeries.

The sealant contains the proteins fibrinogen and thrombin, which are obtained from human blood donors. Although the donors are screened for blood-borne viruses and infections, the risk for disease transmission cannot be discounted, the FDA reported.

The decision has been taken after the FDA reviewed study data featuring 135 abdominal surgery patients. Adverse events during the clinical trial included anemia, abdominal abscess, blockage of the small intestine and loss of urinary bladder tone.

“This approval provides a new option to help control bleeding during general surgery, when other approaches and techniques are ineffective or impractical,” said Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research.

 



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