FDA approves use of surgical sealant

WASHINGTON, May 15 (UPI) -- The U.S. Food and Drug Administration has approved Evicel Fibrin Sealant, a liquid coagulant used 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," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.

The FDA said the product is derived from pooled human plasma and consists of a fibrinogen concentrate and thrombin -- two substances used to promote clotting.

In a study of 147 patients, the effectiveness of Evicel was compared with the standard bleeding control technique of applying pressure to a plastic graft placed over the open blood vessel. Eighty-three percent of those who received Evicel stopped bleeding within 4 minutes, compared with 39.7 percent in the control group.

Evicel is manufactured by OMRIX Biopharmaceuticals LTD, in Kiryat Ono, Israel.