The VenaSeal Sapheon Closure System is not FDA approved and is not commercially available in the United States at this time.

Venous Reflux Disease
Published population studies indicate that approximately 30 million people in the United States and 40 million people in Europe suffer from symptomatic venous reflux disease and experience painful symptoms.
What is Venous Reflux Disease?
Healthy leg veins contain valves that allow blood to move in one direction from the lower limb toward the heart. These valves open when blood is flowing toward the heart and close to prevent venous reflux or the backward flow of blood. When veins weaken and become enlarged, their valves cannot close properly, which leads to venous reflux and impaired drainage of venous blood from the legs. Venous reflux is most common in the superficial veins or those veins closest to the skin. The largest superficial vein is the great saphenous vein, which runs from the top of the foot to the groin, where it attaches and drains to a deep vein called the common femoral vein.

Venous reflux can be classified as either asymptomatic or symptomatic, depending on the degree of severity. Symptomatic venous reflux disease is a more advanced stage of the disease and can have a profound impact on the patient's quality of life. People with symptomatic venous reflux disease may seek treatment due to a combination of signs and symptoms, which may include:

  • leg pain and swelling
  • painful varicose veins
  • skin changes such as discoloration or inflammation
  • open skin ulcers

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What Do Varicose Veins Look &
Feel Like?

Varicose veins typically appear bulging and rope-like. They often lead to aching, tired and swollen legs and cause muscle cramps and a general restlessness in the legs.
Factors that contribute to venous reflux disease include female gender, heredity, obesity, lack of physical activity, multiple pregnancies, age, past history of blood clots in the legs and professions that involve long periods of standing. According to population studies, the prevalence of visible tortuous varicose veins, a common indicator of venous reflux disease, is up to 15% for adult men and 25% for adult women. A clinical registry of over 1,000 patients shows that the average age of patients treated for venous reflux is 48. Over 72% of these patients are women.

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How Does This Happen?

When veins weaken and become enlarged, their valves cannot close properly, which leads to venous reflux and impaired drainage of venous blood from the legs.
A primary goal of treating symptomatic venous reflux is to eliminate the reflux at its source, usually the great saphenous vein. If a diseased vein is either closed or removed, blood automatically re-routes into other veins without any negative consequences to the patient.

A Widespread Problem
In Europe, approximately 40 million people suffer from symptomatic venous reflux disease. About 700,000 patients are treated annually.

In Asia-Pacific countries, an estimated 150 million people suffer from symptomatic venous reflux disease.

An estimated 30 million people in the United States have symptomatic venous reflux disease. Approximately 400,000 saphenous vein procedures are performed in the U.S. annually.

Based on the prevalence of the disease and its potentially debilitating outcomes, the economic impact of venous reflux is significant.