Questions &Answers: The Closure® Procedure:

What is the Closure procedure?

A minimally-invasive surgical procedure that uses radiofrequency energy to occlude, or close, the saphenous vein. The Closure system received marketing clearance in the U.S. in March 1999. As of January 2004, more than 40,000 Closure procedures have been performed worldwide.

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Does it work?

Yes. In extensive clinical tests involving more than 300 patients conducted in Europe and the United States, VNUS Medical Technologies has demonstrated that the Closure system is effective at occluding veins and significantly reducing patient symptoms. Also, published studies have found that at 12 and 24 months following the Closure procedure, over 90% of treated veins remained reflux free and a significant reduction of limb pain, fatigue and edema (swelling) was observed.

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How does it work?

The Closure catheter delivers bipolar radiofrequency energy directly into the vein wall. The passage of heat through the vein wall as the catheter is withdrawn causes resistive heating which shrinks the vessel. The Closure catheter’s flexible electrodes cause the vessel to collapse around the catheter thereby closing the vein and eliminating "valve leakage”, or reflux.

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What are the patient benefits?

Unlike vein stripping, the Closure procedure is minimally invasive, requiring no general anesthesia and lets most patients walk out of the medical facility within hours. Conversely, stripping is often performed under general anesthesia which necessitates a longer time within the medical facility. Convalescence following stripping can take weeks and involve significant pain.

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Are patients satisfied?

98% of patients surveyed at 6 months post-Closure would be willing to recommend Closure to a friend with similar leg vein problems.

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Why doesn't Closure eliminate varicose veins, like those frequently seen in people's calves?

Over a period of years skin which has been deformed by varicose veins undergoes a structural change. Even though Closure helps "normalize" the pressure in a leg, the damage done to the veins by years of reflux may be irreversible. Such veins may not always respond like healthy, elastic tissue when pressure is reduced. In such cases, physicians typically perform additional procedures to remove the remaining varicose veins after the VNUS Closure is completed.

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After the saphenous vein is occluded, or closed, can it grow back?

In theory, blood flow can resume. However, the probability of the saphenous vein reopening is less than 10% at 3 years. One published report found that at 2 years 90% of Closure treated veins were invisible to ultrasound, suggesting permanent obliteration.

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What patients can be treated?

That decision rests with individual physicians. Experience has shown that the vast majority of patients with superficial venous reflux disease can be treated with the Closure procedure.

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How was Closure developed?

The Closure technology and procedure were developed over a four year period by a team of medical engineers, in association with a Silicon Valley physician inventor with more than 125 patents.

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What does the procedure cost?

VNUS Closure is covered by almost all insurance companies as long as reflux is identified on ultrasound and symptoms are identified.

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How long does the procedure take?

The procedure is done in the procedure room in the office and take about 30 minutes. Local anesthesia is used. Patients can drive themselves home soon afterward and resume relatively normal activities later in the day

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If both legs undergo Closure procedures and a vein is later needed for a heart bypass, would the surgeon be able to harvest another vein in lieu of the saphenous vein?

Yes. Most cardiac surgeons prefer to use an internal mammary artery (IMA) for heart bypasses. Also, the saphenous vein below the knee may serve as an appropriate bypass conduit.

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