FDA Approves EVARREST(TM) Fibrin Sealant Patch

SOMERVILLE, N.J., Dec. 7, 2012 /PRNewswire/ -- Ethicon Biosurgery, Division of Ethicon, Inc., a worldwide leader in hemostasis and sealing solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved EVARREST(TM) Fibrin Sealant Patch, a novel product that rapidly and reliably aids in stopping problematic bleeding during surgery. Unexpected and uncontrollable bleeding during surgery poses a significant challenge to surgeons, and in some surgical procedures can raise the patient's mortality rate to 20%.[1]

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EVARREST(TM) 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 control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical. It is not for use in children under one month of age and it cannot safely or effectively be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.

"The FDA approval of EVARREST(TM) 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. "EVARREST(TM) combines the company's expertise in biomaterials and plasma-derived biologics to bring true innovation to surgeons and their patients."