Ethicon Biosurgery announced that the FDA has approved Evarrest Fibrin Sealant Patch, a topical product 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, when control of bleeding by standard surgical methods of hemostasis (eg suture, ligature, cautery) is ineffective or impractical. 

Evarrest consists of a coating of human thrombin and fibrinogen, which react to initiate a fibrin clot. This then integrates into the patch providing mechanical support and adherence to the wound site.

Clinical studies showed that Evarrest was 98% effective in stopping bleeding and maintaining hemostasis vs. the current standard of care at 53%. Effectiveness was defined as stopping bleeding within four minutes of identification of mild to moderate bleeding without re-bleeding for up to 10 minutes.

For more information call (877) ETHICON or visit www.ethicon.com.