Biologic Sealant Patch Delivers Hemostatic Efficacy

The EVARREST Fibrin Sealant Patch is a novel, bioabsorbable hemostat which contains embedded biologics—human thrombin and fibrinogen—that promote rapid and durable clot formation by augmenting the human coagulation system. The technology is comprised of a 10.2 × 10.2 cm flexible composite patch that incorporates the embedded thrombin and fibrinogen, a backing of Polyglactin 910 non-woven fibers, and an oxidized regenerated cellulose (ORC) padding layer.

The patch is positioned with manual compression for three minutes as an adjunct to hemostasis of soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery, when control of bleeding by standard surgical methods of hemostasis, such as sutures, ligature, and cautery are ineffective or impractical. Studies have demonstrated that the EVARREST is greater than 94% effective in controlling bleeding across challenging patient types and surgical situations, compared to current standard of care (less than 53%).

The Ethicon EVARREST Fibrin Sealant Patch is a product of Ethicon (Somerville, NJ, USA), and current approval for use by the US Food and Drug Administration (FDA) has been expanded for use in adult liver surgery.

“We see EVARREST as a game changer - better equipping surgeons to handle bleeding, thereby potentially improving patient outcomes, reducing OR costs and providing peace of mind for the entire surgical staff,” said Dan Wildman, vice president of global franchise strategy and innovation for Ethicon.

“The liver is a particularly hard-to-control bleed site during surgery, as blood loss is often higher and hemostasis may be difficult to achieve,” said Krishna Athota, MD, a trauma and critical care surgeon at the University of Cincinnati (OH, USA). “This expanded indication for EVARREST reinforces this innovation's potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery.”

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