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VISTASEAL™ Fibrin Sealant (Human)
VISTASEAL™ mimics the clot formation process and forms a rapid, adherent, and durable clot regardless of the patient’s coagulation profile1,2 Please see Important Safety Information below.
Features & Benefits
Resources
Resources
Resources
VISTASEAL Product Overview Video
08:31
VISTASEAL In-service Video
08:37
VISTASEAL Assembly Comparison - Frozen
04:31
VISTASEAL Assembly Comparison - Thawed
05:08
VISTASEAL Fibrin Sealant Mechanism of Action
04:17
Supporting Documentation
Product Support
VISTASEAL Ordering Fact Sheet
VISTASEAL Optimized Device Performance Quick Guide
VISTASEAL Sales Aid
Specifications
|
Product Code |
Description |
|---|---|
| VST10 | VISTASEAL Fibrin Sealant (Human), 10 mL |
|
Product Code |
Description |
|---|---|
| 04VST10 | VISTASEAL Fibrin Sealant (Human) 10 mL–4 pack Kit |
|
Product Code |
Description |
|---|---|
| 12VST10 | VISTASEAL Fibrin Sealant (Human) 10 mL–12 pack Kit |
|
Product Code |
Description |
|---|---|
| VSTL35 | VISTASEAL Laparoscopic Dual Applicator 35 cm Rigid |
|
Product Code |
Description |
|---|---|
| VSTL45 | VISTASEAL Laparoscopic Dual Applicator 45 cm Flexible |
References
*Based on number of set-up steps and thawing time required for VISTASEAL™ Dual Applicator vs competitors.
†Refers to 10 mL TISSEEL device.
1. VISTASEAL™ Fibrin Sealant (Human). Full Prescribing Information. Instituto Grifols, S.A. 2019.
2. Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the efficacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to cellulose sheets in hepatic surgery resections. J Gastrointest Surg. 2018. 22:1939-1949.
3. Chetter I, Stansby G, Sarralde JA, et al. A prospective, randomized, multicenter clinical trial on the safety and efficacy of a ready-to-use fibrin sealant as an adjunct to hemostasis during vascular surgery. Ann Vasc Surg. 2017;45:127-137.
4. Hunt BJ. Bleeding and coagulopathies in critical care. N Engl J Med. 2014;370:847-859.
5. Thawing time and set-up steps comparison between VISTASEAL, EVICEL, and TISSEEL. Report 100708726-Rev 2. August 28, 2019. Ethicon, Inc.
6. TISSEEL [Fibrin Sealant] Prescribing Information. Baxter Healthcare Corporation.
7. Completion report for manual spray coverage area. 100682978. December 18, 2018. Ethicon, Inc.
VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION
INDICATION
VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. VISTASEAL is effective in heparinized patients.
CONTRAINDICATIONS
Do not inject directly into the circulatory system.
Do not use for the treatment of severe or brisk arterial bleeding.
Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products.
Do not use VISTASEAL for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.
WARNINGS AND PRECAUTIONS
Thromboembolic events may occur if VISTASEAL is administered intravascularly.
Only spray VISTASEAL if it is possible to accurately judge the distance from the spray tip to the tissue surface.
Hypersensitivity reactions can occur.
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.
ADVERSE REACTIONS
The most common adverse reactions (reported in >1% of clinical trial subjects) were nausea and procedural pain.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
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© Ethicon US, LLC. 2019.
For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.
This site is published by Ethicon US, LLC, which is solely responsible for its contents, and is intended for U.S. audiences only.
This site is intended for Healthcare Professionals. If you are a patient, it is important that you discuss information about the benefits and risks of products with your doctor.
Last updated February 20, 2019. The third-party trademarks used herein are trademarks of their respective owners. Data and usage fees may apply. See your carrier for more information.
