Sealant Helps Stem Bleeding During Surgery
WEDNESDAY Jan. 16, 2008 -- A liquid fibrin sealant to help control bleeding during general surgery has been approved by the U.S. Food and Drug Administration.
Fibrin is a protein that encourages blood to clot. The sealant, Evicel, is applied to small vessels to stem oozing blood.
Evicel contains two proteins, fibrinogen and thrombin, that are involved in the production of fibrin. The proteins are derived from human plasma, which is screened and tested for blood-borne infections. "While the potential risk for infectious disease transmission is remote, it cannot be eliminated," the FDA said in a prepared statement.
Evicel's safety and effectiveness were established in clinical studies involving 135 patients. Adverse reactions included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder function.
Evicel's predecessor, Crosseal, was approved in 2003 for use during liver surgery. The sealant became Evicel last May when the FDA sanctioned its use during vascular surgery. The product is made by an Israeli company, OMRIX Biopharmaceuticals.
The FDA has more about this approval.
Posted: January 2008