EVARREST® Fibrin Sealant Patch Gains FDA Approval on Expanded Indication for General Hemostasis

SOMERVILLE, N.J., Oct. 25, 2016 /PRNewswire-USNewswire/ -- Ethicon* announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for EVARREST^® Fibrin Sealant Patch, which leverages biologics to rapidly and reliably stop problematic bleeding during surgery. The expanded indication supports the use of EVARREST^® as an adjunctive hemostat across a broad range of challenging patient types and surgical situations. This represents a significant milestone in controlling problematic bleeding situations with high confidence, while advancing patient care.

Problematic bleeding that is more than routine and resistant to conventional means of control is one of the most threatening complications of surgery² and a frequent cause of negative patient outcomes, posing significant clinical and economic challenges.^3,4 In patients treated with hemostatic agents for a variety of surgical procedures, bleeding complications were still found to occur in 32% to 68% of surgical cases.⁴

EVARREST^® demonstrated superior hemostatic efficacy on the first attempt, and consistently outperformed conventional adjunctive hemostatic methods in a broad range of challenging patient types and surgical situations, including coagulopathic and anticoagulated patients.¹ The cardiovascular clinical study that supported the expanded indication for EVARREST^® demonstrated its superior hemostatic efficacy against Tachosil^® Fibrin Sealant Patch in a head-to-head clinical study.^1,5

"I'm usually very conservative when using new products but I think EVARREST stands out as one of those products that has made a difference in our practice," said Dr. John A. Kern, Thoracic and Cardiac surgeon at the University of Virginia (UVA) Health System. "I've used EVARREST to manage troublesome bleeding from soft tissue in the thoracic cavity and have been impressed with the results. It's incredibly effective and much easier to use than other available hemostats."

In addition to superior hemostatic efficacy in controlling problematic bleeding situations, EVARREST^® has been shown to deliver 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 adjunctive hemostats.⁶

"The general hemostasis indication for EVARREST offers surgeons expanded options for safe and effective adjunctive hemostasis," said Oray Boston, Worldwide Vice President, Biosurgicals at Ethicon. "Ethicon offers a comprehensive portfolio of best-in-class surgical products and EVARREST is just one of many examples of how our science-based innovative solutions and high quality technologies enable surgeons to achieve superior hemostatic efficacy and improve patient care."

With the FDA's most recent approval, EVARREST^® is now indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. EVARREST^® also can be used in laparoscopic surgery and other minimally invasive surgeries, where manual compression can be achieved.⁷ Limitations for Use: 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.

About EVARREST^®

EVARREST^® is part of a comprehensive portfolio of best-in-class surgical products, providing truly differentiated value to surgeons. It is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature and cautery) is ineffective or impractical.

EVARREST^® represents the convergence of biologics and a medical device (flexible patch) that when combined, form an innovative product 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, providing a durable mechanical structure for integrated clot formation.^{7 8}

To use the product, surgeons place EVARREST^® upon the bleeding wound surface and apply manual compression for three minutes. EVARREST^® remains in the patient's body once surgery has been completed as it is fully bioabsorbable in approximately 8 weeks.

About Ethicon

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the family of Johnson & Johnson companies, 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.

MEDIA CONTACT:

Krys Monaco
513-337-8256
[email protected]

* 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®. All other trademarks are the property of their respective owners.

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Important Safety Information

Indications and Usage

EVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and 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.
• Not for use in children under one month of age
• Laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve.

Important Safety Information

For topical use only. Apply immediate manual compression over the entire surface of the patch and maintain contact pressure for 3 minutes to control the bleeding.

Do not apply intravascularly. This can result in life threatening thromboembolic events.

Do not use to treat bleeding from large defects in arteries or veins where the injured vascular wall requires conventional surgical repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST® to blood flow and/or pressure during absorption of the product. Thrombosis can occur if absorbed systemically.

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. EVARREST ® 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, around, or in proximity to, foramina in bone or areas of bony confines 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.

Use in patients who have been previously exposed to EVARREST® has not been studied.

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 adverse reactions reported during clinical trials occurred in less than 1% of all cases and included deep venous thrombosis, pulmonary embolism, blood fibrinogen increase, anastomotic hemorrhage, post procedural and intra-abdominal hemorrhage, abdominal distension, anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, localized intra-abdominal fluid collection, cardiac failure, operative hemorrhage, and ischemic bowel.

Pediatrics: Use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as recommended.

Please see package insert for EVARREST® Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact ETHICON Customer Support Center at 1-877-384-4266 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the ramifications of an expanded indication for 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 and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; manufacturing difficulties and delays; 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 January 3, 2016, 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 nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

¹ *EVARREST demonstrated hemostatic superiority across 4 clinical trials. Trial 1: Soft Tissue hemorrhage (Per protocol efficacy measured at n=87, safety assessed at n=141) 98.3% vs 53.3% for Surgicel Δ 46.7% P<0.0001 Trial 2: Normal and Abnormal liver resection hemorrhage (Per protocol efficacy measured at n=77, safety assessed at n=104) 94.3% vs 28.6% for conventional adjunctive methods Δ 65.7% P<0.0001 Trial 3: Anatomic and nonanatomic liver resection hemorrhage (Per protocol efficacy measured at n=48, safety assessed at n=102) 97.9% vs 44.4% for conventional adjunctive methods Δ 53.5 P<.0001 Trial 4: Aortic reconstruction (Per protocol efficacy measured at n=141, safety assessed at n=156) 78.8% vs 46.7% for Tachosil Δ 32.1% P<0.0001
² 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.
³ 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.
⁴ Corral M, Ferko N, Hollman S, Broder M, Chang E, Sun G (2014) Health and Economic Consequences of Controlled versus Uncontrolled Surgical Bleeding in Patients Treated with Haemostatic Agents: A Retrospective Analysis of the Premier Perspective Database. SABM(abstract # Houston,TX, USA. Sept 11-13, 2014
⁵ Koea JB. Oral Presentation. 11th E-AHPBA Congress; April 21–24, 2015; Manchester, UK.
⁶ 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.
⁷ EVARREST® Fibrin Sealant Patch [prescribing information]. Somerville, NJ: Ethicon, Inc.
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.

SOURCE Ethicon

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