TISSEEL [Fibrin Sealant]

For full prescribing information, please view the package insert (pdf 105k).

• TISSEEL is indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature and cautery, is ineffective or impractical.
• TISSEEL is not indicated for the treatment of massive and brisk arterial or venous bleeding.
• TISSEEL has been shown to be an effective sealant as an adjunct in the closure of colostomies.
• TISSEEL is a satisfactory hemostatic agent in fully heparinized patients undergoing cardiopulmonary bypass.
• TISSEEL has shown better cosmetic outcomes with reduced incidence of complications in ARB surgeries.
• TISSEEL is an effective sealant in case of CSF leak.

• Tissue sealing starts with fibrin formation, the end stages of natural blood coagulation.
• Fibrinogen is converted to fibrin strands that join into net-like matrices
• Similar to a natural plasma clot, TISSEEL firmly adheres to exposed collagenol This results in a clot with the following characteristics
• Tensile strength- Provides greater tensile strength- ten times stronger than a high salt, non-physiologic fibrin sealant clot
• Elasticity- TISSEEL clot has a high level of elasticity
• Physiological- a physiological clot is easy to see, unlike the colorless transparent fibrin clots of non-physiological preparations

• Manufactured using thoroughly screened plasma, a two-step vapor heating process and a solvent/detergent treatment process
• Satisfactory for use in fully heparinized patients undergoing cardiopulmonary bypass
• It's the same TISSEEL that you have always trusted, with over 25 years of clinical use and 15 million cases without a single confirmed transmission of HIV, Hepatitis A, B,or C associated with TISSEEL

Do not inject TISSEEL directly into blood vessels. Intravascular application of TISSEEL may result in life-threatening, thromboembolic events.
TISSEEL is contraindicated in individuals who are known to be hypersensitive to bovine proteins.
TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
As with any other protein products, hypersensitivity or allergic/anaphylactoid reactions may occur in very rare cases.
Especially in coronary bypass surgery, TISSEEL should be applied with caution to minimize any risk of inadvertent intravascular application. The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated.
Please see accompanying full Prescribing Information.

1. TISSEEL [Fibrin Sealant] Full Prescribing Information, 07/2006.
2. Sierra D., Fibrin sealant adhesive systems: a review of their chemistry, material properties and clinical applications. Journal of Biomaterial Applications. Vol 7. 1993: 309-352.
3. Carr M., Martin E., et al. Fibrin sealants. Encyclopedia of Biomaterials and Biomedical Engineering. 2004:611-620.
4. Redl H, Schlag G. Properties of Different Tissue Sealants with Special Emphasis on Fibrinogen-Based Preparations. Fibrin Sealant in Operative Medicine, Otohinolaryngology. Vol 1. Berlin, Heidelberg: Springer-Verlag; 1986:27-38.
5. Data on file. Baxter Healthcare Corporation.