VenaSeal

The VenaSeal™ closure system is the only non-thermal, non-tumescent, non-sclerosant procedure approved for use in the U.S. that uses an advanced medical adhesive that closes the diseased vein. The system has been shown to be effective in three clinical studies, with demonstrated safety and high closure rates.3,4,5,7,8

VenaSeal Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Greater Saphenous Veins (VeClose Pivotal Study)
VeClose pivotal study is a prospective, randomized study comparing the VenaSeal™ closure system to radiofrequency ablation. The study enrolled 242 patients at 10 sites across the U.S. The VeClose pivotal study continues to demonstrate safety and efficacy of the VenaSeal™ closure system with closure rates of 95.3 percent at 24 months.17

European Sapheon Closure System Observational ProspectivE (eSCOPE)
European Sapheon Closure System Observational ProspectivE (eSCOPE) was a prospective, multicenter, single-arm study that enrolled 70 patients at seven sites in Europe. Results from the study published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders demonstrate that the VenaSeal™ closure system had a cumulative closure rate of 88.5 percent and improvement in quality of life scores at 36 months.5

VenaSeal™ Closure System – Feasibility Study
The feasibility study for the VenaSeal™ closure system was a prospective, single-center study to demonstrate the feasibility, safety and efficacy. The study enrolled 38 patients. Results of the trial demonstrated the safety and efficacy of the procedure, with closure rates at 94.7 percent at 36 months.16

How it works

The VenaSeal™ closure system is the only non-thermal, non-tumescent, non-sclerosant procedure approved for use in the U.S. that uses a specially formulated medical adhesive that closes the diseased vein. This unique approach eliminates the risk of thermal nerve injury that is sometimes associated with certain thermal-based procedures.8 The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks.4,5 Patients also report minimal-to-no bruising post procedure.8

Prepare the VenaSeal™ closure system
A trained clinician fills a syringe with the medical adhesive, which is inserted into the VenaSeal™ closure system’s dispensing gun that is attached to a catheter.

Deliver adhesive and compression sequences
The catheter is advanced into the diseased vein under ultrasound guidance.
The catheter is placed in specific areas along the diseased vein and the clinician conducts a series of trigger pulls to deliver the medical adhesive. Compression is applied to the leg during the procedure.

Frequently Asked Questions

What is venous reflux disease?
Healthy leg veins have valves that keep blood flowing to the heart. Venous reflux disease, also known as chronic venous disease, develops when the valves stop working properly and allow blood to flow backward (i.e., reflux) and pool in the lower leg veins. If venous reflux disease is left untreated, symptoms can worsen over time. As a result, vein valves will not close properly, leading to symptoms such as:

  • Varicose veins
  • Leg pain, aching or cramping
  • Leg or ankle swelling
  • Leg heaviness and fatigue
  • Skin changes or rashes
  • Ulcers, open wounds or sores

How prevalent is venous reflux disease?

  • More than 190 million people have CVI or varicose veins globally.3 (More than 30 million Americans) suffer from varicose veins, or the more serious form of venous disease called chronic venous insufficiency (CVI), yet the majority remains undiagnosed and untreated.1,2
  • Venous reflux disease, also known as chronic venous insufficiency, affects more than 30 million Americans.1,2
  • Varicose veins, a common symptom of venous reflux disease, can affect up to 40 percent of adults.11
  • Varicose veins are more common in those who are overweight, and in women who have had more than two pregnancies.11
  • Women usually have multiple risk factors for the development of varicose veins. In fact, varicose veins are most common in women (75 percent of those diagnosed) than in men (25 percent of those diagnosed).12
  • Up to 55 percent of American women may be affected by varicose veins in their lifetime.13
  • It is common for varicose veins to become more prominent during pregnancy and worsen with successive pregnancies.13

How is venous reflux disease treated?
Venous reflux disease treatment aims to reduce or stop the backward flow of blood. Treating the diseased vein improves overall blood flow and relieves symptoms.
For some patients, compression stockings alone may improve blood flow. For other patients, closing or removing the diseased vein may be necessary to improve blood flow. Closing or removing the diseased vein directs blood to nearby healthy veins.

What is the VenaSeal™ closure system?
The VenaSeal™ closure system is the only non-thermal, non-tumescent, non-sclerosant procedure approved for use in the U.S. that uses a specially formulated medical adhesive that closes the diseased vein.

What does it treat?
The VenaSeal™ closure system treats symptomatic venous reflux disease in the lower extremity superficial truncal veins, often the underlying cause of painful varicose veins.

How does it work?
During the procedure, a trained clinician fills a syringe with the medical adhesive, which is inserted into the VenaSeal™ closure system’s dispensing gun that is attached to a catheter. The catheter is advanced into the diseased vein under ultrasound guidance. The catheter is placed in specific areas along the diseased vein and the clinician conducts a series of trigger pulls to deliver the medical adhesive. Compression is applied to the leg during the procedure.

Is there clinical data to support the use of the VenaSeal™ closure system?
The VenaSeal™ closure system has been shown to be effective in three clinical studies, with demonstrated safety and high closure rates.3,4,5,7,8

  • The VeClose pivotal study demonstrates safety and efficacy of the VenaSeal™ closure system with closure rates of 95.3% percent at 24 months. 17
  • Results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study published in the Journal of Vascular Surgery demonstrate a cumulative closure rate of 88.5 percent and improvement in quality of life scores at 36 months.5
  • Closure rates in the Feasibility Study were 94.7 percent at 36 months.3,4

How does the VenaSeal™ closure system differ from thermal energy procedures?
The VenaSeal™ closure system uses an adhesive to close the vein. Thermal energy uses heat to close the vein.
The intense heat requires a large volume of dilute numbing medicine, which is injected through multiple needle sticks. The injections may cause pain and bruising after the procedure.

How quickly can patients return to normal activities post procedure?
The VenaSeal™ closure system procedure is designed to minimize patient discomfort and reduce recovery time. After the procedure, a small bandage will be placed at the access site. Patients are able to rapidly return to normal activities.5
Additionally, patients have reported minimal bruising following the VenaSeal™ closure system procedure.8

How can patients learn more about venous reflux disease and the VenaSeal™ closure system?
Visit our practice website to learn more about venous reflux disease, and the clinical and lifestyle related benefits associated with the VenaSeal™ closure system.

Is treatment with the VenaSeal™ closure system suitable for everyone?
The VenaSeal™ closure system should not be used in patients who have a known hypersensitivity to the VenaSeal™ closure system’s adhesive, acute inflammation of the veins due to blood clots, or acute whole-body infection.
Adverse events observed in the VenaSeal™ closure system trials—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone.
A vein specialist can tell you if the VenaSeal™ closure system is the right option for your situation.

What happens to the treated vein left behind in the leg? Don’t I need it?
Faulty valves interfere with the normal return of blood through the venous system. Closing these diseased veins helps to re-route the blood through nearby veins, improving circulation and relieving most symptoms. The adhesive was designed to remain permanently in the GSV and is eventually encapsulated by chronic fibrotic growth for vein closure.15

Is the VenaSeal™ closure system procedure covered by insurance?
As with any procedure, insurance coverage may vary. Those interested in the VenaSeal™ closure system should contact their insurance provider for more information.

1 Gloviczki, P, Comerota, A, Dalsing, M, Eklof, B, Gillespie, D, Gloviczki, M, et al. The care of patients with varicose veins and associated chronic venous diseases: Clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May; 53 (5 Suppl): 2S-48S.
2 US Markets for Varicose Vein Treatment Devices 2011, Millennium Research Group. 2011.
3 Almeida JI, Javier JJ, Mackay E, Bautista C, Proebstle™. First human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2013;1:174-180.
4 Almeida JI, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle™. Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Phlebology / Venous Forum of the Royal Society of Medicine 2014.
5 Proebstle™, Alm J, Dimitri S et al. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2015;3(1):2-7.
6 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings, and B. Eklof, Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. British Journal of Surgery Society. www.bjs.co.uk, March 15, 2011.
7 Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery. 2015;61(4):985–994.
8 Morrison, N. Use of Cyanoacrylate adhesive for Treatment of Incompetent Great Saphenous Veins: 12-month Results of the VeClose Trial, European Venous Forum, 2015.
9 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 2016.
10 Kolluri, Raghu: VenaSeal™ Sapheon Closure System vs. Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) Kolluri, R. VeClose two-year data. Charing Cross 2016.
11 Tisi, P. Varicose veins. Clin Evid (Online). 2011. http://www.ncbi.nlm.nih.gov/pubmed/21477400.
12 American College of Phleboloby. Patient FAQs. http://www.phlebology.org/patientinfo/faq.html#varicoseveins.
13 American College of Phleboloby. Treatment of varicose and spider veins. http://phlebology.org/images/resources/Varicose_Vein_Brochure_Redesign.pdf.
14 Pannier F et al. The relevance of the natural history of varicose veins and refunded care. Phlebology 2012; 27 Suppl 1:23-26.
15 Lui, DM et al., Cyanoacrylate Embolization for the Treatment of Saphenous Vein Reflux: Ultrasound Appearance and Correlative Findings of Comparative Model Histology. ACP 2014.
16 Medtronic. (2014). Sapheon™ Closure System Feasibility Study Print Date Final Clinical Study Report, CR-10669-03 (Rev A). Morrisville, NC: Giovino, K.
17 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.

Meet Our Doctors

Meet Our Doctors

Eddy H. Luh, MD FACSVascular Surgeon

Dr. Eddy Luh graduated from Cornell University. He then received his medical degree from the University of Vermont College of Medicine. Dr. Luh completed his General Surgery residency here in Nevada at the University of Nevada Affiliated Hospitals. He then trained at the world renowned ...

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