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Devices Surgery FDA

 News Release - April 6, 2015

FDA Expands Indication for EVARREST(R) Fibrin Sealant Patch

Surgeons Have New Solution for Controlling Problematic Bleeding Situations During Adult Liver Surgery

SOMERVILLE, N.J., April 6, 2015 -- (Healthcare Sales & Marketing Network) -- Unexpected and uncontrollable bleeding is an ongoing challenge for surgeons, including those who perform liver surgery. Based on recent data, the U.S. Food and Drug Administration has approved an additional indication for Ethicon's EVARREST® Fibrin Sealant Patch, as an adjunct to hemostasis for control of bleeding during adult liver surgery. 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.

A problematic bleeding situation—involving bleeding that is more than routine and resistant to conventional means of control—is one of the most threatening complications of surgery1 and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges.2,3 First attempts to control surgical bleeding using current hemostatic agents can fail up to 50 percent of the time.3

"The liver is a particularly hard-to-control bleed site during surgery, as blood loss is often higher and hemostasis may be difficult to achieve," said Krishna Athota, M.D.*, trauma and critical care surgeon at the University of Cincinnati College of Medicine. "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 a novel, bioabsorbable hemostat that delivers a powerful combination of hemostatic efficacy, adherence and mechanical strength.4,5,6 The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation by augmenting the human coagulation system. 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.

Clinical studies demonstrate that EVARREST is greater than 94 percent effective in controlling bleeding across challenging patient types and surgical situations, compared to current standard of care (less than 53 percent).7,8,9 EVARREST provides a rapid, predictable solution for problematic bleeding, minimizing surgical procedure disruption.3,7,8

"We see EVARREST as a game changer—better equipping surgeons to handle bleeding, thereby potentially improving patient outcomes, reducing OR costs and providing peace of mind for the entire surgical staff," said Dan Wildman, Vice President of Global Franchise Strategy and Innovation for Ethicon.

EVARREST has been shown to deliver a cost savings compared with current standard of care, when taking into account hemostat cost, OR time, transfusion requirements and retreatment. The low rate of re-bleeding with EVARREST reduces the need for other hemostatic therapies.10

About EVARREST®

EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and 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.

EVARREST represents the convergence of biologics and medical device (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.

About Ethicon**

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

*Dr. Athota is a paid consultant of Ethicon, LLC.

**Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.

Ethicon, Inc. is the legal manufacturer of EVARREST.

Important Safety Information

Indications and Usage

EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding during open retroperitoneal, intra-abdominal, pelvic, and non-cardiac thoracic surgery in adults when control of bleeding by standard surgical methods of hemostasis (e.g., suture, ligature, cautery) is ineffective or impractical.

Limitations for Use

Cannot be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding.

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. Apply topically to the bleeding site only. 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 (e.g., in, around, or in proximity to, foramina in bone or areas of bony confine) where swelling may cause compression.

Use the least number of patches required to cover the entire bleeding area. Portions of excess patch material can become dislodged and migrate to other areas of the body.

Do not use more than eight 2x4 inch (5.1 x 10.2 cm) or more than four 4x4 inch (10.2 x 10.2 cm) patches per single surgical procedure.

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.

Adverse reactions from repeat use (during a subsequent surgical procedure) have not been evaluated. A second application, at the original site of application (during a subsequent surgical procedure) may result in multiple organ adhesions, increased inflammation, fibrosis, encapsulated tissue and/or necrosis and hemorrhage (re-bleeding).

The adverse reactions reported during clinical trials were blood fibrinogen increased, post procedural and intra-abdominal hemorrhage, abdominal distension, anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, post-procedural bile leak, abdominal abscess, ascites, deep vein thrombosis, localized intra-abdominal fluid collection, and pulmonary embolism.

Please see package insert for EVARREST Full Prescribing Information.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the EVARREST®Fibrin Sealant Patch. 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 known 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: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ethicon, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

1 Schreiber MA, Neveleff DJ. Achieving hemostasis with topical hemostats: making clinically and economically appropriate decisions in the surgical and trauma settings. AORN J. 2011;94(5):S4-S20.

2 Stokes, et al. Impact Of Bleeding-Related Complications And/Or Blood Product Transfusions On Hospital Costs In Inpatient Surgical Patients. BMC Health Services Research 2011, 11:135.

3 Data on File, Ethicon, Inc. Global Health Economics and Market Access. EVARREST® Fibrin Sealant Patch. Global Value Dossier Slide Deck.

4 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.

5 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.

6 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.

7 Fischer C. et al. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93.

8 Koea JB, Batiller J, Patel B, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013;15(1):61–70.

9 Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.

10 Corral M et al. Cost Analysis of a Fibrin Sealant Patch for Mild, Moderate and Problematic Soft Tissue Surgical Bleeding: A Hospital Perspective, Cornerstone Research Group.


Source: Ethicon

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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