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Proven superior to TachoSil® Fibrin Sealant Patch
EVARREST was clinically proven to achieve hemostasis more reliably than TachoSil® Patch in a multi-center, randomized study in aortic reconstruction surgery, achieving hemostasis in 3 minutes in 78.8% of cases vs 46.7% (per protocol). EVARREST demonstrated superior hemostatic efficacy in 4 randomized controlled clinical trials across a spectrum of challenging bleeding situations and surgical procedures.1-4*
Superior in an array of situations2-5
Blood seeps in, doesn’t pool underneath
After appropriate application and manual compression for 3 minutes, blood seeps into the EVARREST patch rather than pooling beneath it. Blood activates fibrinogen and thrombin to form a clot. Hemostasis is achieved when the clot integrates with the patch and adheres to the tissue surface.6
Superior hemostatic efficacy on the first attempt1-4*
32%-68% of cases in open procedures experience disruptive bleeding events. Challenging and uncontrollable bleeding during surgery is associated with increased mortality rates. When challenging bleeding strikes, surgeons need superior hemostatic efficacy.1-4,7,8*
Conforms to a wide range of surgical sites
The patch’s adhesive strength forms a tight yet flexible physical seal that maintains a barrier to bleeding, conforming to a wide range of surgical sites.6
*EVARREST demonstrated hemostatic superiority across 4 clinical trials. Trial 1: Soft Tissue hemorrhage: Per protocol efficacy measured at n=87, 100% vs 53.3% for Surgicel Δ 46.7% P<0.0001; (ITT population=90). Trial 2: Normal and Abnormal liver resection hemorrhage: Per protocol efficacy measured at n=77, 94.3% vs 28.6% for conventional adjunctive methods Δ 65.7% P<0.001; (ITT population=84). Trial 3: Anatomic and nonanatomic liver resection hemorrhage: Per protocol efficacy measured at n=93, 97.9% vs 44.4% for conventional adjunctive methods Δ 53.5% P<0.0001; (ITT population=102). Trial 4: Aortic reconstruction: Per protocol efficacy measured at n=141, 78.8% vs 46.7% for Tachosil Δ 32.1% P<0.0001; (ITT population=156).
1. Kocharian R. A single-blinded, randomized, controlled, comparative Phase III study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery. BIOS-13-004. December 3, 2015. Ethicon, Inc.
2. Fischer CP, et al. Clinical Study Report 400-07-002. 20 November 2009. Ethicon, Inc.
3. 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.
4. Garden OJ, Kocharian R, et al. A phase III randomized, controlled, superiority study evaluating EVARREST™ Fibrin Sealant Patch versus standard of care treatment in controlling parenchymal bleeding during hepatic surgery. Clinical study report code BIOS-13-005. November 13, 2014. Ethicon, Inc.
5. Koea J, Baldwin P, Shen J, 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.
6. EVARREST® Fibrin Sealant Patch Prescribing Information. Ethicon, Inc.
7. Corral M, Ferko N, Hollman S, Broder MS, Chang E. Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database. Clinicoecon Outcomes Res. 2015;7:409-421.
8. Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of bleeding in surgery. Transplant Proc. 2006;38(3):812-814.
EVARREST® Fibrin Sealant Patch
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.
Dosage and Administration
For topical use only
• Determine the number of patches to be applied based upon the surface area and anatomic location of the bleeding tissue to be treated.
• Keep the patch dry until use.
• Place the powdery (active) side of the patch on the surface of tissue.
• Apply immediate manual compression over the entire surface of the patch and maintain contact pressure for 3 minutes to control the bleeding.
Dosage Forms and Strengths
EVARREST® Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component. The active side is powdery, and the non-active side has an embossed wave pattern.
Each 2 x 4 inch (5.1 x 10.2 cm) absorbable patch contains:
• 55.5 mg per square inch (8.6 mg per square cm) human fibrinogen
• 241.9 Units per square inch (37.5 Units per square cm) human thrombin
• Do not use to treat bleeding from large defects in arteries or veins.
• Do not apply intravascularly.
• Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
Warnings and Precautions
• 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, 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.
• 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.
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.
USE IN SPECIFIC POPULATIONS
Pediatric: 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.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.