Superficial vein

VenaSeal™ closure system

<p>The VenaSeal™ closure system delivers immediate and lasting vein closure with its proprietary medical adhesive formula.</p>

Ordering information

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Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual/s.Please note that the intended use of a product may vary depending on geographical approvals. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For applicable products, consult instructions for use on this website http://manuals.medtronic.com/manuals/main/region.For a MRI compatible device, consult the MRI information in the device manual before performing a MRI.For any further information, contact your local Medtronic representative.

Features

The VenaSeal™ closure system procedure offers:

Rapid return to normal activities after treatment^1,3
Minimized pain, tenderness, and ecchymosis³
Significant improvements in quality of life⁶

The VenaSeal™ closure system procedure eliminates:^2,4

Tumescent anesthesia
Thermal nerve injury
Post-procedure compression stockings^†

Benefits

View an illustration of VenaSeal™ adhesive being placed in the vein via a small catheter.

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 mL aliquots with each trigger pull.

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.⁷

See a gloved hand holding a VenaSeal™ adhesive bottle with syringe.

Viscosity

The viscosity of the adhesive is specifically designed to minimize migration and embolization.

A man in a blue t-shirt and shorts stands in a pose while taking a yoga class.

Flexibility

The adhesive is designed to be soft and flexible, and less likely to be felt by the patient.

System components

Adhesive
Plunger
Release button
Trigger
Dispensing tip
Catheter

The VenaSeal™ closure system with callouts to detail its separate components.

Kit specifications

VenaSeal™ adhesive	Five mL 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 mL (range: 0.06–0.12 mL) 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 mL 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.

Clinical evidence

Great outcomes

Long-term evidence with high clinical standards

View the evidence

9 of 10

Patients would choose VenaSeal™ procedure again at five years⁵

75%

Improvement in VCSS scores at five years⁵

94.6%

Closure rate at five years⁵

Ordering information

VenaSeal™ system

Item number	Description
VS-403	Glass vial with 5 mL adhesive, dispenser gun, 5 Fr x 91 cm catheter, 7 Fr x 80 cm introducer, 5 Fr x 87 cm dilator, (2) 3 mL syringes, (2) 14 ga dispenser tips, guidewire: 0.035 in (0.89 mm) 180 cm straight floppy-tip

Similar products

ClosureFast™ radiofrequency ablation (RFA) system

The ClosureFast™ procedure uses radiofrequency energy to treat patients with superficial vein disease.

TM*Third-party brands are trademarks of their respective owners.

†Demonstrated in C2–C4 patients.

‡Some patients may benefit from the use of compression stockings post-procedure.

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. 2015;61(4):985–994.
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. 2021;9(2):329–334.
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. 2017;25(2):149–156.
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. 2017;5(5):658–666.
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. 2020;8(6):978–989.
Morrison N, Gibson, Vasquez M, et al. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg. 2017;5(3):321–330.
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.
Proebstle TM, Alm BJ, Gockeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg. 2015;102(3):212–218.
Gibson K, Glorieux K. VenaSeal versus ablation with endothermal laser or radiofrequency for saphenous vein incompetence: a comparison of utilization of adjunctive phlebectomy (VenaSeal value). Presented at AVLS 2019. Abstract available at: journals.sagepub.com/doi/full/10.1177/0268355519893876. Accessed November 5, 2021.
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. 2017;5(3):321–330.

This product is licenced with Health Canada as VENASEAL CLOSURE SYSTEM on Health Canada licence number MDL : 91988.

VenaSeal™ closure system