The FDA has approved the marketing of Evicel Fibrin Sealant, a liquid topical that controls oozing from small blood vessels during surgical procedures.
“Evicel provides an effective means to stop oozing from small vessels during vascular surgery when suturing, compression, or other standard techniques are not effective or practical,” says Jesse Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research.
Evicel Fibrin Sealant, manufactured by Omrix Biopharmaceuticals in Kiryat Ono, Israel, is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances that promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission. However, the potential risk for the transmission of blood-borne viruses cannot be totally eliminated.
In a study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique—applying pressure to a plastic covering (graft) placed over the open blood vessel. The results showed that 83% of those who received Evicel stopped bleeding within 4 minutes compared with 40% in the control group.
Side effects, such as anemia and graft site infection were generally mild and occurred at about the same frequencies in the Evicel-treated group and the control group.
[FDA, May 15, 2007]