EVICEL® Fibrin Sealant (Human)
Rely on EVICEL® Fibrin Sealant (Human)
EVICEL™ Airless Spray Accessory is designed to deliver a rapid, adherent, and lasting fibrin clot2
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 profile1,2
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.
No treatment-site bleeding was observed 7 to 14 days postsurgery1
In a prospective, single-arm observational study of 300 patients, no recurrence of treatment-site bleeding was found for up to four weeks post-op.3 The study included patients using antiplatelets and anticoagulants (e.g., heparin), patients with coagulopathies, and patients with a range of comorbidities.
Ready when you need it
More convenient to prepare, use and store compared to TISSEEL
EVICEL Fibrin Sealant can be stored frozen/refrigerated and can last up to 30 days at 2◦C - 8◦C once thawed. EVICEL can be thawed in a warm water bath (33◦C-37◦C), at room temperature or in a refrigerator. EVICEL can be used within 24 hours of being brought to room temperature. EVICEL can be applied at temperatures between 2◦C-37◦C.
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
3. Post-Authorization Safety Surveillance (PASS). Start date: June 4, 2010. End date: May 21, 2014
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.