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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)

Complex problem. Simple solution.

The only all human, aprotinin free fibrin sealant indicated for general hemostasis. EVICEL Fibrin Sealant, once thawed, is ready on-demand to meet your critical bleeding challenges by working independently of your patient’s clotting factors.

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Rely on EVICEL® Fibrin Sealant (Human)

Sustained hemostasis

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.

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Established safety

For a rapid, adherent and lasting clot

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.

EVICEL - Established Safety

Ready when you need it

More convenient to prepare, use and store compared to TISSEEL

EVICEL Fibrin Sealant can be stored refrigerated or frozen and can last up to 30 days (at 2C - 8C) once thawed. While thawing, EVICEL Fibrin Sealant can be used in a warm water bath (33C-37C), room temperature or refrigerator. In addition, EVICEL Fibrin Sealant can be used in 33C-37C (warm water bath or incubator) or 2C-33C temperatures.

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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
 

EVICEL® Fibrin Sealant (Human)

IMPORTANT SAFETY INFORMATION
Indications

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.

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