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
* 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
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
venous system, often the underlying cause of painful
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
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.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.