A Medical Device Daily

The FDA yesterday reported the market approval of Evicel Fibrin Sealant, a liquid product, made by OMRIX Biopharmaceuticals (Kiryat Ono, Israel), that when applied topically helps control oozing from small blood vessels during surgical procedures.

Jesse Goodman, MD, director of the agency's Center for Biologics Evaluation and Research (CBER), said, "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."

Evicel is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin, two substances used to promote clotting. Both substances go through a two-stage process to reduce the risk of viral transmission in manufacturing.

CBER said in a statement, however, that "the potential risk for the transmission of blood-borne viruses cannot be totally eliminated."

In a pivotal study of 147 patients, Evicel was compared with the standard bleeding control technique of applying pressure to a plastic covering (graft) placed over the open blood vessel. Of those who received Evicel, 83% stopped bleeding within four minutes, compared with 39.7% in the control group.

Adverse events, 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, according to the FDA.

The agency originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery.