An innovative solution that can stop problematic bleeding on the 1st attempt. * 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. It may look ordinary, but what it does is extraordinary... • 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. ...like stopping bleeding in tumor bed, liver resection, and aortic reconstruction in 3 minutes.1-6 • 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 F:12" 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. Combining thousands of woven fibers and active human biologics.4,5 • Use in patients who have been previously exposed to EVARREST® has not been studied. Combining thousands of woven fibers and active human biologics.4,5 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. • No preparation, mixing, or moistening with saline required • Does not require refrigeration • Shelf life of 30 months7 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. 030813-150309= Ask about attending a live lab to see EVARREST in action *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) 100% 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<0.0001. 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. References: 1. Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. 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;217(3):385–393. 2. 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. 3. Koea J, Baldwin P, Shen J, Patel B et al. Safety and hemostatic effectiveness of the fibrin pad for severe soft-tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic (non-cardiac) surgery: a randomized, controlled, superiority trial. World J Surg. 2015;39(11):2663-2669. 4. Moainie S, Chen E, Al-Attar N, et al. A phase III, randomized, controlled superiority trial evaluating EVARREST® Fibrin Sealant Patch versus Tachosil Fibrin Sealant Patch in controlling bleeding in aortic reconstruction surgery. Abstract presented at The Houston Aortic Symposium; March 3 – 5, 2016. 5. EVARREST® Fibrin Sealant Patch [prescribing information]. Somerville, NJ: Ethicon, Inc. 6. Data on file. Ethicon, Inc. EVARREST® Fibrin Sealant Patch, Dossier. 7. FDA Approval Letter 03.03.2016. © 2017 Ethicon US, LLC. All rights reserved. 061681-161014 *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) 100% 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<0.0001. 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. Studies demonstrated no increased risk of thromboembolic events in patients treated with EVARREST. 1,2 All adverse reactions were seen in less than 1% of all cases.5 Disclaimer: The primary endpoints of these studies did not include an evaluation of the safety and efficacy of EVARREST in these specific procedures. Distal pancreatectomy Radical cystectomy Aortic valve and root repair Aortic dissection Aortic aneurysm repair Lung resection Abdominoperineal resection Retroperitoneal tumor resection Tissue to vascular prosthetic graft anastomosis4 Cirrhotic and steatotic liver parenchyma2 Nonanatomic liver resections 3 Open surgical procedures studied include: Patients with increased body mass index and obesity1-3 Retroperitoneal and pelvic soft tissue bleeding1 EVARREST consistently outperformed conventional adjunctive methods in a broad range of challenging patient types and surgical situations, including: EVARREST demonstrated superior hemostatic efficacy in 4 randomized controlled clinical trials across a spectrum of challenging bleeding situations and surgical procedures.1-4 * THE EFFICACY F:8.875" Filename: 722239-1_p4_Evarrest_Extra_Sales_Aid.indd CLIENT: PRODUCT: JOB#: SPACE: BLEED: TRIM: SAFETY: GUTTER: PUBS: ISSUE: TRAFFIC: ART BUYER: ACCOUNT: RETOUCH: PRODUCTION: ART DIRECTOR: COPYWRITER: IMAGES: Ethicon_CMYK.ai patch2_4c_145p.psd CMYK 300 ppi Screen Shot 2014-07-08 at 3.24.44 PM_4c.psd 31550_rem_Front_4_simp-low-res_106p.psd CMYK CMYK Johnson & Johnson Ethicon 722239-1 None 27.875” x 24.25” 27.625” x 24” None 0” x 0” None None None None None None M. Siegel None None Proof #: 4 Path: EG-PLUS-NY:Volumes:EG-PLUS-NY:EGPlus_ Departments:Print:A‚ÄîF:DDB:Johnson&Johnson:Current Jobs:Ethicon:722239-1_Evarrest_Extra_Sales_Aid:7222391_p4_Evarrest_Extra_Sales_Aid.indd Operators: beata_molska / anthony_seminara Ink Names: Magenta Yellow Black Dieline OOH Scaling Info: Build Scale: 100% Final Safety : 24” H x 27.625” W Final Viewing Area : 24” H x 27.625” W Final Trim : 24” H x 27.625” W Final Bleed : 24.25” H x 27.875” W Created: 3-8-2017 1:21 PM Saved: 3-8-2017 1:23 PM Printed: 3-8-2017 1:23 PM Print Scale: None Fonts: Stag San