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FDA Expands Indication for Evarrest Fibrin Sealant Patch
Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the FDA has approved an additional indication for the Evarrest fibrin sealant patch (Ethicon, Inc.) as an adjunct to hemostasis for the control of bleeding during adult liver surgery.
A problematic bleeding situation — involving bleeding that is more than routine and that is resistant to conventional means of control — is one of the most threatening complications of surgery and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges. First attempts to control surgical bleeding using current hemostatic agents can fail up to 50% of the time.
Evarrest is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis to control bleeding during adult liver surgery and soft-tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, and cautery) are ineffective or impractical.
The flexible composite patch contains embedded human biologics (human thrombin and fibrinogen proteins) that are involved in the natural clotting process. The biologic components react and initiate a fibrin clot, which then integrate into the patch, providing mechanical support and adherence to the wound site.
Surgeons place the Evarrest patch on the bleeding wound surface and apply manual compression for approximately 3 minutes. The patch remains in the patient’s body after surgery has been completed as it is fully bioabsorbable.
In clinical studies, the Evarrest patch was more than 94% effective in controlling bleeding across challenging patient types and surgical situations compared with the current standard of care, which was less than 53% effective.
Source: PR Newswire; April 6, 2015.