Does the potential of Fibrin Sealants for minimally invasive surgery remain largely unexplored? Will the FDA approval and general hemostasis in surgery indication for EVICEL expand the market potential? Will EVICEL now actively be promoted for a wider range of surgical applications?
…the U.S. Food and Drug Administration has granted an expanded indication for general hemostasis in surgery for EVICEL(TM) Liquid Fibrin Sealant (Human). EVICEL is the first liquid fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical…
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. The pivotal study included in the last submitted clinical supplement is entitled: A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding during Retroperitoneal or Intra-abdominal Surgery.
In this clinical study, EVICEL was shown to be superior to the control product (Surgicel(R), oxidized regenerated cellulose) in achieving hemostasis in less than 10 minutes. Superiority was also established at the secondary efficacy endpoints of 7 and 4 minutes.
About EVICEL
EVICEL is the only all human plasma-derived liquid fibrin sealant commercially available in the U.S. It does not contain aprotinin, which has been associated with adverse health effects. EVICEL is easy to use and readily available for time-sensitive needs in the operating room. The product is sold as a frozen liquid and requires less than one minute preparation time after thawing. It can be stored for 30 days as a ready-to-use liquid preparation at refrigerator temperature, a significant competitive advantage…
Post a Comment