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.

VISTASEAL™ Fibrin Sealant (Human)

Resources

Resources

VISTASEAL Product Overview Video
VISTASEAL Product Overview Video
08:31
VISTASEAL In-service Video
VISTASEAL In-service Video
08:37
VISTASEAL vs TISSEEL Open Spray Comparison
VISTASEAL vs TISSEEL Open Spray Comparison
02:07
VISTASEAL Variable Spray
VISTASEAL Variable Spray
01:29
VISTASEAL Traditional Drip vs. Focused Spray
VISTASEAL Traditional Drip vs. Focused Spray
01:32
VISTASEAL Laparoscopic Tip Handling (Trocar)
VISTASEAL Laparoscopic Tip Handling (Trocar)
01:27
VISTASEAL Assembly Comparison - Frozen
VISTASEAL Assembly Comparison - Frozen
04:31
VISTASEAL Assembly Comparison - Thawed
VISTASEAL Assembly Comparison - Thawed
05:08
VISTASEAL Fibrin Sealant Mechanism of Action
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

Instructions For Use

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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