This bleeding-control sealant was originally only approved for use in liver surgeries in 2003.
A recent study of 147 patients indicated great success of bleeding control with the use of the sealant, which was pivotal in the FDA's decision to expand its use for other surgeries, too.
The sealant was effective in stopping the bleeding within four minutes among the majority of study participants.
The topical liquid sealant is applied during surgical procedures and helps control the oozing of blood from small vessels.
"Evicel provides an effective means to stop oozing from small [blood] vessels during vascular surgery when suturing, compression or other standard techniques are not effective or practical," said the Director of the FDA's Center for Biologics Evaluation and Research, Jesse Goodman, M.D., M.P.H.
However, according to the FDA news release, "the potential risk for the transmission of blood-borne viruses cannot be totally eliminated."
It is possible for graft site infection or anemia to occur with the sealant procedure. Notably, these same ill effects were just as prevalent with the old-fashioned pressure technique to control bleeding.
Therefore, the benefits of the sealant apparently outweigh any detrimental effects, thus leading to its approved expanded usage.
