FDA Approves Evarrest
FDA Approves Evarrest 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 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 bio-absorbable.
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.
Important Safety Information
For topical use only. Do not apply intravascularly.
Do not use to treat bleeding from large defects in arteries or veins.
Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
Thrombosis can occur if absorbed systemically.
Can cause hypersensitivity reactions including anaphylaxis.
Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur.
Evarrest contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur.
Avoid use in closed spaces where swelling may cause compression.
Use the least number of patches required to cover entire bleeding area. Do not use more than four patches.
May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most common adverse reactions reported during clinical trials (≥ 1%) were abdominal distension, blood fibrinogen increased, post procedural and intra-abdominal hemorrhage, and pulmonary embolism.
Please see package insert for Evarrest Full Prescribing Information.
About Ethicon Biosurgery
The Evarrest Fibrin Sealant Patch joins a portfolio of best-in-class products that complement surgical techniques and surgeon experience so they can achieve efficiencies and success in surgery. With nearly 50 years of proven experience in hemostasis, Ethicon Biosurgery is committed to delivering innovative and life-saving surgical solutions to surgeons that address a range of bleeding and leaking situations – from routine to problematic – during surgical procedures. These solutions can be used for open and minimally invasive procedures across a broad range of specialties and includes proprietary oxidized regenerated cellulose hemostats; gelatin powder and sponges; a flowable hemostatic matrix; human thrombin, and fibrin sealant. Ethicon Biosurgery is a division of Ethicon, Inc., a trusted leader in surgical care.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ethicon, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
 Marietta, M et al. Pathophysiology of bleeding in surgery. Transplantation Proceedings, 38, 812-214 (2006)
 Data on File. Effectiveness defined as stopping bleeding within four minutes of identification of mild to moderate bleeding without re-bleeding up to 10 minutes.
SOURCE Ethicon Biosurgery
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Posted: December 2012