The FDA cleared Ethicon Biosurgery’s Evarrest fibrin sealant patch for use during surgery to help stop problematic bleeding, which can raise a patient’s mortality rate to 20% in some cases, the company said.
The Evarrest features a coating of biologics, which can initiate a fibrin clot and help form a flexible patch that adheres to a wound, according to the press release.
"The FDA approval of Evarrest is a significant milestone in advancing patient care. We believe this technology has the potential to drive a paradigm shift in the treatment of problematic bleeding during surgery," president Dan Wildman said in prepared remarks. "Evarrest combines the company’s expertise in biomaterials and plasma-derived biologics to bring true innovation to surgeons and their patients."
The device can help when standard surgical methods are "ineffective or impractical," Ethicon noted. Clinical studies have shown that the Evarrest system is 98% effective in stopping bleeding and maintaining hemostasis, compared with a 53% rate for the current standard of care.
The Evarrest is not for use in children under 1 month and can not take the place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding, the company said.