The company said that the approval of the general hemostasis in surgery indication is based on the submission of clinical data related to three pivotal studies conducted in three different surgical procedures with challenging bleeding. In the pivotal study included in the last submitted clinical supplement, Evicel was shown to be superior to the control product (Surgicel, oxidized regenerated cellulose) in achieving hemostasis in less than 10 minutes. Superiority was also established at the secondary efficacy endpoints of seven and four minutes.
Robert Taub, president and CEO of Omrix, said: “Although fibrin sealants have been commercially available in the US since 1999, their potential remains largely unexplored. FDA approval of the clinical supplement and general hemostasis in surgery indication for Evicel are important developments as they significantly expand the market potential for this product and bring us closer to our stated objective of creating a one-stop-shop for biological hemostats. Ethicon, our marketing partner, will now actively promote Evicel for a wide range of surgeries.”