VenaSeal™ closure system for superficial vein therapies
Reach new lengths and treat more diseased vein with VenaSeal closure system. The VenaSeal closure system delivers immediate and lasting vein closure with its proprietary medical adhesive formula, with a demonstrated 94.6% closure rate at 5 years.1-5
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Overview
Reach new lengths
Treat more diseased vein.
Maximize your impact.
Maximize patient comfort and recovery.
Simpler procedure, faster recovery1-4,6,7
- Nonthermal
- No risk of thermal nerve injury
- Less pain and bruising than thermal treatment1,2
- Nontumescent
- Limited needle sticks
- Rapid recovery with same-day return to daily activities
- No post-procedure compression stockings†2,4
Adverse events can include allergic reaction, inflammation, phlebitis, deep vein thrombosis, and/or pulmonary embolism.
Clinical evidence
VenaSeal Spectrum Program
Next-level evidence for venous care
The VenaSeal Spectrum Program is the largest post-market clinical study of the VenaSeal closure system compared to the current standards of care.
Product details
Immediate vein closure
Deliver immediate and lasting vein closure with our proprietary medical adhesive.1-5
Maximize efficiencies
View a VenaSeal closure system procedure animation to see how the single, double, and triple segment treatment options work.
The VenaSeal closure system procedure offers:
- Rapid return to normal activities after treatment1,3
- Minimized pain, tenderness, and ecchymosis3
- Significant improvements in quality of life6
The VenaSeal closure system procedure eliminates2,4:
- Tumescent anesthesia
- Thermal nerve injury
- Post-procedure compression stockings†
Features and benefits
Precision
The proprietary catheter is highly visible under ultrasound, allowing precise delivery of the adhesive. The dispensing gun precisely controls the amount of adhesive, delivering 0.10 cc aliquots with each trigger pull.8
Polymerization
Upon contact with blood, the adhesive begins to bond with the intima and compression is applied to close the vein. The adhesive was designed to remain permanently in the diseased vein and is encapsulated by chronic fibrosis.9
Viscosity
The viscosity of the adhesive is specifically designed to minimize migration and embolization.9
Flexibility
The adhesive is designed to be soft and flexible, and less likely to be felt by the patient.9
Patient testimonials
Steve's story
Hear about Steve's experience with the VenaSeal closure system.
Heather's story
Hear about Heather's experience with the VenaSeal closure system.
Indications
The VenaSeal closure system (VenaSeal system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
Technical resources
Instructions for use can be found in the product labeling at manuals.medtronic.com.
System components
- Adhesive
- Plunger
- Release button
- Trigger
- Dispensing tip
- Catheter
Model specifications
|
Description
|
Specs
|
|---|---|
| VenaSeal adhesive |
Five cc of the VenaSeal adhesive (a specially formulated n-butyl-2-cyanoacrylate) is contained within a screw-capped vial. |
| Dispenser gun |
The dispenser gun consists of a pistol-type ergonomic handle with an integrated barrel and trigger. Each depression of the trigger delivers a controlled 0.10 cc (range: 0.06–0.12 cc) amount of adhesive. |
| Catheter |
The catheter is 5 Fr with an effective length of 91 cm, laser markings at 3 cm and 85 cm from the tip, and high echogenic visibility. |
| Introducer |
The introducer is 7 Fr with an effective length of 80 cm, with 10 mm spaced circumferential markings along its length for measuring retraction length during the VenaSeal procedure. |
| Dilator |
The dilator is 5 Fr with an effective length of 87 cm. |
| Syringe |
The 3 cc syringes are graduated Monoject™* Luer Lock syringes, each with a standard threaded Luer Lock connector. |
| Dispenser tips |
The dispenser tips are each comprised of a stainless steel, 1.5 mm ID, 3.8 cm length hypotube with a Luer Lock connector. |
| Guidewire |
The guidewire is a 0.035 in, 180 cm straight floppy-tip guidewire. |
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*
™ Third-party brands are trademarks of their respective owners.
†
Some patients may benefit from the use of compression stockings post-procedure.
References
1
Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. April 2015;61(4):985–994.
2
Proebstle T, Alm J, Dimitri S, et al. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. March 2021;9(2):329–334.
3
Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular. April 2017;25(2):149–156.
4
Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Thirty-sixth month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphat Disord. September 2017;5(5):658–666.
5
Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. November 2020;8(6):978–989.
6
Morrison N, Gibson K, Vasquez M, et al. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. May 2017;5(3):321–330.
7
Morrison, N. VenaSeal Closure System vs. Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). 36-Month Results presented at: IVC; April 20, 2017; Miami, FL.
8
Reference report DVR-10815.
9
Reference report 10570943DOC.