Healthcare Professionals

VenaSeal Closure System 

SUPERFICIAL VEIN THERAPIES

OVERVIEW

The VenaSeal™ closure system offers relief for patients suffering from chronic venous insufficiency by using a proprietary medical adhesive to permanently close the diseased 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.

  • Nonthermal
  • Nontumescent
  • Nonsclerosant

VenaSeal Procedure Animation

View this VenaSeal Closure System procedure animation to see how it works.
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DISCOVER THE VENASEAL SYSTEM DIFFERENCE

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

Backed by Long-term Data

VeClose Extension Study 5-year Results4

Purpose: Follow-up study to assess the long-term safety and efficacy of the VenaSeal closure system.

  • VenaSeal closure system closure rates remained strong at 5-year follow-up.
  • No DVT, PE, or adhesive-related allergies were reported in the VenaSeal closure system cohort.
VenaSeal Closure System VeClose Extension Study Key Findings

DESIGNED FOR PATIENT COMFORT

Legs before and 3 months after VenaSeal procedure

Individual results may vary.

Image provided by Dr. Kathleen Gibson.

The VenaSeal closure system procedure offers:

  • Rapid return to normal activities after treatment5,6
  • Minimized pain, tenderness and ecchymosis6
  • Significant improvements in quality of life7

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

Morrison, N. VeClose Extension Study Five-year Results. Presented at Charing Cross, April 16, 2019; London, UK.

5

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.

6

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. 

7

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.