Venaseal™ Vein Closure in Sherman Oaks, Los Angeles.

Introducing the Venaseal™ closure system

What is the VenaSealclosure system?

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 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 venous system, 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 VenaSealclosure 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

  • Closure rates in the first in human trial were 92 percent at 12 and 24 months, respectively.3,4
  • Results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study published in the Journal of Vascular Surgery demonstrate a cumulative closure rate of 92.9 percent and improvement in quality of life scores at 12 months.5
  • The twelve month results of the VeClose pivotal study demonstrates safety and efficacy of the VenaSeal™ procedure with demonstrated closure rates of 97.2 percent.8

How does the VenaSealprocedure 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.

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

Is treatment with the VenaSealclosure 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 procedure trials—and generally associated with treatments of this condition—included temporary vein inflammation (phlebitis) and temporary 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.13

 

References:

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.

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. et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal of Vascular Surgery. January 30, 2015. DOI: http://dx.doi.org/10.1016/j.jvs.2014.11.071

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 Tisi, P. Varicose veins. Clin Evid (Online). 2011. http://www.ncbi.nlm.nih.gov/pubmed/21477400

10 American College of Phleboloby. Patient FAQs. http://www.phlebology.org/patientinfo/faq.html#varicoseveins

11 American College of Phleboloby. Treatment of varicose and spider veins. http://phlebology.org/images/resources/ Varicose_Vein_Brochure_Redesign.pdf

12 Pannier F et al. The relevance of the natural history of varicose veins and refunded care. Phlebology 2012; 27 Suppl 1:23-26

13 Lui, DM et al., Cyanoacrylate Embolization for the Treatment of Saphenous Vein Reflux: Ultrasound Appearance and Correlative Findings of Comparative Model Histology. ACP 2014

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