EVARREST® Fibrin Sealant Patch
Seeing is Believing
Innovative solution that can stop problematic bleeding on the 1st attempt.*
Surgeons need an innovative adjunctive-solution that can achieve 1st-attempt efficacy to minimize the disruptions and potential consequences of problematic bleeding situations.
EVARREST Innovation offers superior hemostatic efficacy on the 1st attempt
EVARREST® Fibrin Sealant Patch demonstrated superior hemostatic efficacy in 4 randomized controlled clinical trials across a spectrum of challenging bleeding situations and surgical procedures.
Ready to use, right out of the box
EVARREST® does not require preparation, mixing, moistening with saline or refrigeration, and has a shelf life of 30 months.1
EVARREST® Fibrin Sealant Patch PI
* 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<.0001Trial 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
1. EVARREST® Fibrin Sealant Patch [prescribing information]. Somerville, NJ: Ethicon, Inc.
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.