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A broad portfolio that provides flexibility to help minimize the risk for complications.See our portfolio of products for hepato-biliary procedures navigate_next
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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.
EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.
- Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events.
- Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
- Do not use for the treatment of severe or brisk arterial bleeding.
- Do not use EVICEL® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip to the target site cannot be ensured.
Warnings and precautions
- Life-threatening gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at pressures higher than recommended and/or at distances closer than recommended to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of gas embolism.
- Monitor changes in blood pressure, pulse oxygen saturation, and end-tidal CO2 when spraying EVICEL® because of the possibility of gas embolism.
- To reduce the risk of potentially life-threatening gas embolism, spray EVICEL® using only pressurized CO2 gas at the recommended pressures and distances.
- Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures. Apply as a thin layer.
- Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Prepare and administer EVICEL® according to the instructions and only with devices recommended for this product.
- 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.
Most common adverse events reported in clinical trials (>5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, peripheral edema, and constipation.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert
- * Vs. Pringle Maneuver in a prospective randomized controlled trial comparing Pringle Maneuver (n=80) vs. liver resection with Harmonic scalpel (n=80)
- † Based on a retrospective review comparing ultrasonic dissector + HARMONIC vs. clamp crush approach.