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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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