A Clinical Solution

What to Expect

Method of Action

The VenaSeal™  proprietary cyanoacrylate-based adhesive safely and effectively closes the diseased vein segment.1-6

5.Internal Compression 2

  • VenaSeal™ adhesive is delivered in 0.10 cc allotments along the length of the targeted vein segment.

  • The propriety catheter is highly visible under ultrasound, for precise delivery of the adhesive.

  • The procedure can be completed in an office or hospital setting and requires no additional capital equipment.

Veins treated with the VenaSeal™ Closure System 30 Days Post-procedure

3.3.2 Phy VS ultrasound 30 day

The above ultrasound image shows a chronic foreign body reaction leading to fibrous occlusion in treated veins.

12 Months Post-procedure

3.2.2 Phy VS ultrasound 1 yr

The VenaSeal™ adhesive is sonographically dense, as demonstrated by the shadowing in the above image.

Recovery

Demonstrated Results

The VenaSeal™ closure system was shown to be effective in three clinical studies, with demonstrated safety and high closure rates.♦4-6

 

 

VS_legs_side-by-sideIndividual Results May Vary

Patient Comfort

The VenaSeal™ closure system is designed to minimize patient pain and reduce recovery time2-6

  • Rapid return to normal activities2

  • Tumescent-free solution-no multiple needle sticks

  • Minimal-to-no bruising6

  • No post-procedure compression stockings1,2,4,5*

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

Minimally Invasive

Non-tumescent, Non-thermal, Non-sclerosant

  • A new treatment option for your patients

  • Designed to improve patient comfort and allow rapid return to normal activities2-6

  • Non-tumescent, non-thermal and non-sclerosant procedure minimizes needle sticks

  • Eliminates risk of thermal injury

  • No post-procedure compression stockings*

  • Supported by clinical evidence across three clinical studies2-6

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

Potential Risks

As with all medical procedures, there is a chance that complications may occur, including, but not limited to the following:

•Allergic reaction to the VenaSeal™ adhesive
•Arteriovenous fistula (i.e., an abnormal connection between an artery and a vein)
•Bleeding from the access site
•Deep vein thrombosis (i.e., blood clot in the deep vein system)
•Edema (i.e., swelling) in the treated leg
•Hematoma (i.e., the collection of blood outside of a vessel)
•Hyperpigmentation (i.e., darkening of the skin)
•Infection at the access site
•Neurological deficits including stroke and death
•Non-specific mild inflammation of the cutaneous and subcutaneous tissue
•Pain
•Paresthesia (i.e., a feeling of tingling, pricking, numbness or burning)
•Phlebitis (i.e., inflammation of a vein)
•Pulmonary embolism (i.e., blockage of an artery in the lungs)
•Urticaria (i.e., hives) or ulceration may occur at the site of injection
•Vascular rupture and perforation
•Visible scarring

 

References:

1. Almeida JI, Javier JJ, Mackay EG, Bautista C, Proebstle TM. First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous and Lymphat Disord. 2013;1(2):174-80.

2. Proebstle TM, Alm J, Dimitri S et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous and Lymphat Disord.

3. Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radio frequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg.

4. Almeida J. Three-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. AVF 2015.

5. Proebstle, Thomas: The European Multicenter Study on Cyanoacrylate Embolization of Refluxing Great Saphenous Veins without Tumescent Anesthesia and without Compression Therapy – Proebstle, T. eSCOPE three-year data. Charing Cross 2015.

6.  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.

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