EVICEL® Fibrin Sealant (Human)
EVICEL Fibrin Sealant provides sustained hemostasis, demonstrated in high-risk patients,503 with effective clot formation regardless of patient coagulation profile.503,540
Rely on EVICEL® Fibrin Sealant (Human)
For a rapid, adherent and lasting clot
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.Download product brochure picture_as_pdf
Effective clot formation regardless of patient coagulation profile503,540
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.Watch this video to learn more video_library
No Treatment-site bleeding was observed 7 to 14 days postsurgery503,539
In a prospective, single-arm observarional study of 300 patients, no recurrence of treatment-site bleeding was found for up to four weeks post-op.541 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 or refrigerated and can last up to 30 days at 2◦C - 8◦C (refrigerated temperature) once thawed. EVICEL Fibrin Sealant can be thawed in a warm water bath (33◦C-37◦C), at room temperature or in a refrigerator. In addition, EVICEL Fibrin Sealant can be used within 24 hours of being brought to room temperature. EVICEL Fibrin Sealant can be applied at temperatures that range from 2◦C-37◦C.Contact a representative
EVICEL® Fibrin Sealant (Human)
|DESCRIPTION (TOTAL VOLUME)||CODE||NDC/DISTRIBUTOR CODE||QUANTITY|
|1-mL Kit (2 mL)||3901||67313-390-11||1|
|2-mL Kit (4 mL)||3902||67313-390-22||1|
|5-mL Kit (10 mL)||3905||67313-390-55||1|
|35 cm Rigid Tip||3908||N/A||Set of 3|
|45 cm Flexible Tip||3909||N/A||Set of 3|
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.
Important Risk Information
- 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.
- 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.