Ethicon Receives FDA Clearance for Sealant Patch
Ethicon Biosurgery, a division of Ethicon, has announced it has received FDA approval for its EVARREST fibrin sealant patch, according to a news release (pdf).
EVARREST is designed to aid in stopping problematic bleeding during surgery. It 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 is 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 of Ethicon Biosurgery, in the release. "EVARREST combines the company's expertise in biomaterials and plasma-derived biologics to bring true innovation to surgeons and their patients."
Ethicon is a Johnson & Johnson Company.
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