What is the VenaSeal Vein Closure System?

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 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 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 the safety and efficacy of the VenaSeal™ closure system with closure rates of 94.3 percent at 24 months.10

■ 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, respectively.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. 17 The intense heat requires a large volume of dilute numbing medicine, which is injected through multiple needle sticks. The injections may cause pain and bruise 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

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.