Healthcare Professionals

VenaSeal<br>Closure System

Superficial Vein Products

OVERVIEW

The VenaSeal™ closure system offers relief for patients suffering from venous reflux disease by using a proprietary and proven medical adhesive to permanently close the vein.


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).


PRODUCT DETAILS

With no need for heat, the VenaSeal procedure delivers a comfortable patient experience1,2* and immediate vein closure,1,2 with the results you have come to expect.

  • Non-thermal
  • Non-tumescent
  • Non-sclerosant

Venaseal Procedure Animation

View this VenaSeal Closure System procedure animation to see how it works.
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IMMEDIATE CLOSURE

The VenaSeal closure system provides immediate vein closure, delivering consistent and reproducible results for your patients without the need for post-procedure compression stockings.1,2,**

 

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.

Venaseal Adhesive Placed

Viscosity

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

VenaSeal Adhesive with Syringe

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.3

VenaSeal Polymerization

Flexibility

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

Man stretching

THE RESULTS YOU HAVE COME TO EXPECT

VeClose 36-Month Results (IDE Clinical Trial)3

  • One of the largest multicenter, randomized prospective comparisons of superficial venous ablation technologies
  • No DVT, PE or adhesive-related allergies were reported in the VenaSeal closure system study arm
  • 94.4% closure rate at 3 years

 


A COMFORTABLE PATIENT EXPERIENCE

The VenaSeal closure system procedure offers:

  • Rapid return to normal activities after treatment4,5
  • Minimized pain, tenderness and ecchymosis5
  • Significant improvements in quality of life6

The VenaSeal closure system procedure eliminates:1,2

  • Tumescent anesthesia
  • Thermal nerve injury
  • Post-procedure compression stockings*

TECHNICAL GUIDE

Instructions for use can be found in the product labeling at http://manuals.medtronic.com.


MODEL SPECIFICATIONS

VenaSeal Closure System
DESCRIPTION SPECS

VenaSeal Adhesive

Five (5) cc of the VenaSeal adhesive (a specially formulated n-butyl-2-cyanoacrylate) is contained within a screwed-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 and 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-inch, 180-cm J-wire guidewire.


*

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


1

Proebstle, T.M. The European Multicenter Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins without Tumescent Anesthesia and without Compression Therapy. Results presented at: Charing Cross; 2016; London, UK. 

2

Almeida, J.I., Jacier, J.J., Mackay, E.G., Bautista, C., Cher, D.J. and Proebstle, T.M. Thirty-Sixth Month Follow-up of First-in-human Use of Cyanoacrylate Adhesive for Treatment of Saphenous Vein Incompetence. J Vasc Surg: Venous and Lymphatic Disorders. 2017. Published Online: 2 June 2017.

3

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.

4

Gibson, K., and 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 (2016) May 20, Epub 2016 May, 1708538116651014.

5

Morrison, N., Gibson, K., McEnroe, S., Goldman, M., King, T., Weiss, R., Cher, D., Jones, A. Randomized Trial Comparing Cyanoacrylate Embolization and Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose). J Vasc Surg. 2015;61(4):985–994. 

6

Morrison, N., et al. VeClose Trial 12-month Outcomes of Cyanoacrylate Closure Versus Radiofrequency Ablation for Incompetent Great Saphenous Veins. J Vasc Surg. http://dx.doi.org/10.1016/j.jvsv.2016.12.005.