Broad Portfolio of Products
Surgical treatment improves chances for survival,499,500 however over one-third of hepato-biliary procedures are affected by major complications or comorbidities.501 Ethicon offers a broad portfolio that delivers surgical precision and optimal hemostasis at every critical step of complex hepato-biliary procedures.
Options for precise dissection with efficient sealing capability to help minimize collateral damage.
HARMONIC Technology allowed for less intraoperative blood loss, fewer surgical complications and earlier recovery of liver function after liver resection.494,§
HARMONIC® HD 1000i Shears – seamless combination of precision and strength for improved dissection, faster transection and more secure sealing
HARMONIC ACE®+7 Shears – unites the precision of HARMONIC® with optimal sealing capability for vessels up to 7mm
HARMONIC FOCUS®+ Long Shears – brings greater efficiency to open procedures with an uparalleled level of access, visibility, controlled dissection and sealing consistency compared to traditional techniques*
Adjunctive options for managing bleeding situations, from oozing to problematic†
Surgicel Family of Aborbsable Hemostasts – proven safety and efficacy for managing a broad spectrum of continuous oozing bleeding situations
EVARREST® Fibrin Sealant Patch – stops problematic bleeding situations on the 1st attempt in indicated patients496,497
EVICEL® Fibrin Sealant – provides sustained hemostasis
Options for confidently sealing difficult to access or fragile vessels and ducts
ETHICON ENDO-SURGERY™ Linear Cutter – designed to deliver optimal compression and superior hemostasis‡
ECHELON FLEX™ Powered Vascular Stapler – enables the most precise placement on isolated fragile vesselsβ
ECHELON FLEX™ Powered ENDOPATH® Stapler – greater stability for potentially less tissue trauma¥
Options for secure closure that address risk factors associated with SSIs
STRATAFIX™ Knotless Tissue Control Devices – delivers more consistency, more security and more efficiency497 than traditional sutures122,123,133,141,145,150,153
DERMABOND® PRINEO® Skin Closure System – uncompromised strength and protection for excellent wound closure498
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
- * In a pre-clinical study, 100% (32/32) of porcine blood vessels remained hemostatic over a 30 day survival period.
- † Compared to adjunctive products.
- ‡ Preclinical porcine study comparing the NTLC75, TLC75 and DST Series™ GIA™ 80 (3.8mm cartridge). Hemostasis was evaluated against a 5-point scale, with lower scores representing better hemostasis. Mean scores by instrument: NTLC-2.9, TLC-3.9, and DST series GIA-3.6. The NTLC demonstrated superior hemostasis when compared to the TLC and DST Series GIA, p>0.05.
- § Vs. Pringle Maneuver in a prospective randomized controlled trial comparing Pringle Maneuver (n=80) vs. liver resection with Harmonic scalpel (n=80).
- β Compared to end effector with a smaller curved tip design
- ¥ Benchtop testing on porcine stomach (2.5-4mm thick). Surgeons (n=19) fired each instrument / reload once: PSE60A / ECR60G, 030449 / 030459, and EGIAUSTND / EGIA60AMT. Distal tip motion measurement during the firing cycle showed a 63% reduction in tip movement of PSE60A/ECR60G vs. the other two devices.