J&J's EVARREST Fibrin Sealant Patch Approved by FDA
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 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%.
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 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 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 combines the company's
expertise in biomaterials and plasma-derived biologics to bring true
innovation to surgeons and their patients."
EVARREST consists of a coating of biologics and a flexible patch that, when
combined, form a distinct delivery system that will raise the standard of care
for surgeons and their patients. Each component of EVARREST ^ plays an
active role in the hemostasis process -- the biologics (human thrombin and
fibrinogen) react and initiate a fibrin clot, which then integrate into the
patch, providing mechanical support and adherence to the wound site.
To use the product, surgeons place EVARREST upon the bleeding wound surface
and apply manual compression for approximately three minutes. EVARREST
remains in the patient's body once surgery has been completed as it is fully
Clinical studies demonstrate that EVARREST is 98% effective in stopping
bleeding and maintaining hemostasis compared to the current standard of care
at 53%, potentially minimizing disruption to the surgical procedure.