FDA approves medical patch to be used in adult liver surgeries

The FDA has approved an additional indication for Evarrest, enabling the product to be used as an adjunct to hemostasis for controlling bleeding during adult liver surgery, according to a news release from the distributor.

“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,” Krishna Athota, MD, trauma and critical care surgeon at the University of Cincinnati College of Medicine, said in the release. “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.”

Evarrest (Fibrin Sealant Patch, Omrix Biopharmaceuticals, Ltd.) is intended for use with manual compression as an adjunct to hemostasis for soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic and non-cardiac thoracic surgery, according to the FDA website.

The patch is designed to stop problematic bleeding during surgery on the first attempt in indicated patients and has been over 94% effective in controlling bleeding across various patient types and surgical situations, compared to current standards of care effective at less than 53%, according to the release.

“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,” Dan Wildman, vice president of global franchise strategy and innovation for Ethicon, the company which distributes the product, said in the release.