The US Food and Drug Administration (FDA) has approved Ethicon Biosurgery's new fibrin sealant patch to aid surgeons in stopping problematic bleeding during surgery.
The fibrin sealant patch, EVARREST, comprises a coating of biologics (human thrombin and fibrinogen) which react and initiate a fibrin clot, which then integrate into the patch to provide mechanical support and adherence to the wound site.
EVARREST also contains oxidized regenerated cellulose which adheres to bleeding surfaces.
Upon the bleeding, wound surface is attached with EVARREST and manual compression is applied for three minutes.
In addition, EVARREST has also been indicated 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, claims the company which is a subsidiary of Ethicon.
Clinical studies conducted on EVARREST demonstrate that it is 98% effective in stopping bleeding and maintaining hemostasis compared to the current standard of care at 53%.
Ethicon Biosurgery president Dan Wildman said, "We believe this technology has the potential to drive a paradigm shift in the treatment of problematic bleeding during surgery."