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EVICEL® Fibrin Sealant (Human)
EVICEL Fibrin Sealant provides sustained hemostasis, demonstrated in high-risk patients,1 with effective clot formation regardless of patient coagulation profile.1,2
Features & Benefits
Rely on EVICEL® Fibrin Sealant (Human)
EVICEL™ Airless Spray Accessory is designed to deliver a rapid, adherent, and lasting fibrin clot.2 EVICEL Fibrin Sealant provides sustained hemostasis for bleeding that may be addressed intraoperatively, but could later develop into more serious complications especially in high-risk patients.
Effective clot formation regardless of patient coagulation profile.1,2 EVICEL Fibrin Sealant 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.
Established Safety in a Wide Range of Patients
No recurrence or treatment-site bleeding was found for up to 4 weeks post-op.3 In a prospective, single-arm observational study of 300 patients3: All achieved hemostasis, 66% of patients were treated with heparin; 88% of these patients did not have heparin reversal with protamine prior to treatment with EVICEL Fibrin Sealant. Study included patients with a wide range of comorbidities including obesity, renal disease, and carotid, coronary, and peripheral artery disease.
Ready When You Need It
EVICEL is more convenient to prepare, use, and store than TISSEEL.* Eliminates the need for external gas sources, reducing setup time.4 Application ready in less than 1 minute.† EVICEL™ Airless Spray Accessory takes less time to set up than TISSEEL DUPLOSPRAY System.5 Refrigerator thawed and ready for 30 days versus 2 days for TISSEEL.‡
*TISSEEL is a registered trademark of Baxter International, Inc.
†When at room temperature (20°-25°).
‡EVICEL thaws at 37° only.
The third-party trademarks used herein are trademarks of their respective owners.
1. Chalmers RT, Darling RC III, Wingard JT, et al. Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Br J Surg. 2010;97(12):1784–1789.
2. STAR ASA coverage area test using corium tissue on a 45 degree tilted plane. September 2014. Ethicon, Inc.
3. Post-Authorization Safety Surveillance (PASS). Start date: June 4, 2010. End date: May 21, 2014. Ethicon, Inc.
4. Airless Spray Accessory Design Requirement Matrix. September 15, 2014. Ethicon, Inc.
5. ASA Design Validation Marketing Claims, August 2017. Ethicon, Inc.
EVICEL® Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
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 air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer EVICEL®. This event appears 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.
▪ 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 pressures and distances recommended for the specific tips.
▪ Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures.
▪ 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 with only 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.
The most common adverse reactions reported in clinical trials are peripheral edema, abdominal abscess, infection, hematoma, incision site hemorrhage, vascular graft occlusion, postoperative wound complication and decreased hemoglobin.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.