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US FDA approved indication for Ethicon’s EVARREST Fibrin Sealant Patch

 

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Clinical courses

Ethicon, a part of J&J, received expanded FDA indication for its EVARREST Fibrin Sealant Patch to be used to help control bleeding during adult liver surgeries. The device is bioabsorbable and contains human thrombin and fibinogen proteins that participate in clot formation. It retains its strength and stickiness while it’s still around. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients. EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis . The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.

Liver is a particularly hard-to-control bleed site during surgery. A problematic bleeding situation –that is more than routine most threatening complications of surgery that challenges clinical and economic efficacy. This expanded indication for EVARREST ® reinforces this innovation’s potential to make problematic bleeding situations routine, and could result in a paradigm shift in the treatment of bleeding during surgery.

EVARREST is greater than 94% effective in controlling bleeding across challenging patient. EVARREST provides a rapid, predictable solution for problematic bleeding, minimizing surgical procedure disruption. This is one of best innovation of Ethicon. The low rate of re-bleeding with EVARREST reduces the need for other hemostatic therapies. Surgeons place EVARREST upon the bleeding wound surface and apply manual compression for approximately three minutes. As it is fully bio-absorbable EVARREST remains in the patient's body once surgery has been completed.

Ethicon has made significant contributions to surgery for more than 60 years. Ethicon's continuing improving  health care by solving major issues, and improve and save more lives.


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