FDA approves Ethicon's fibrin sealant patch

ETHICON Biosurgery, a division of Ethicon, Inc (Somerville, NJ), has been granted approval by the US Food and Drug and Administration (FDA) for its EVARREST Fibrin Sealant Patch. This novel product that rapidly and reliably aids in stopping problematic bleeding during surgical procedures.

Evarrest has 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, when standard surgical methods of hemostasis like suture, ligature, and cautery are ineffective or impractical.

“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,” said Dan Wildman, Worldwide president, Ethicon Biosurgery.

The patented fibrin sealant consists of a coating of biologics (human thrombin and fibrinogen) that react and initiate a fibrin clot, which then integrate into a patch, which provides mechanical support and adherence to the wound site. The patch is placed upon the bleeding wound surface by applying manual compression for about three minutes. It can remain in the body after surgery, as it is fully bio-absorbable.

Related information: Evarrest package insert