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Q & A: The Closure Procedure

- What is the Closure procedure?
- Does it work?
- How does it work?
- What are the patient benefits?
- Are patients satisfied?
- After the saphenous vein is occluded, or closed, can it grow back?
- How was Closure developed?
- Is it available in the United States?
- What does the procedure cost?
- Is Closure covered by insurance?
- Does Closure require and operating room?
- Does it require general anesthesia?
- How long does the procedure take?
- Can Closure and other procedures, such as phlebectomy, be done in the same session?
- Does it hurt?
- Is it necessary to be on an anticoagulant (blood thinner) after surgery to prevent clotting?
- Can the same Closure catheter be used on both legs?
- Can a Closure catheter be recycled?
- What potential risks and complications are associated with Closure?
- How long is the recovery period?
- How long after Closure should a patient have a follow-up visit?
- Do insurers regard Closure as a cosmetic procedure?
- 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?

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 March 2003, more than 20,000 Closure procedures have been performed worldwide.- back to top

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, recent published studies have found that at 12 and 24 months following the Closure procedure, 90% of treated veins remained reflux free and a significant reduction of limb pain, fatigue and edema (swelling) was observed.- back to top

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 The passage of heat through the vein wall as the catheter is withdrawn causes resistive heating which shrinks the vessel.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.- back to top

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.- back to top

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.- back to top

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 appears to be no more than 10% out to 2 years. One published report found that at 2 years 90% of Closure treated veins were invisible to ultrasound, suggesting permanent obliteration.- back to top

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.- back to top

Is it available in the United States?
The Closure system received marketing clearance in the US in March 1999.- back to top

What does the procedure cost?
The Closure procedure currently ranges per leg. After the Closure procedure, patients typically experience relatively little discomfort and trauma, allowing them to return to normal activities in a day or two. Many patients report they also preferred Closure over traditional vein stripping because it can be done in non-hospital settings, only requires local anesthesia and has a short recovery period.- back to top

Is Closure covered by insurance?
As with any vein procedure, medical necessity must be established and documented to obtain insurance coverage. Many major health plans have coverage policy for the Closure procedure.- back to top

Does Closure require an operating room?
No. Many physicians performing Closure procedures use ambulatory centers, surgi-centers and/or medical offices.- back to top

Does it require general anesthesia?
No. Most physicians numb the leg and vein with a local anesthetic solution.- back to top

How long does the procedure take?
Approximately 45 minutes, though patients normally spend 2-3 hours at the medical facility due to normal pre and post-treatment procedures.- back to top

Can Closure and other procedures, such as phlebectomy, be done in the same session?
Many physicians who have been doing Closure procedures remove varicose veins via phlebectomy in the same leg during a single operation, if needed.- back to top

Does it hurt?
Although some people are more sensitive than others, few patients complain of any pain. Some have said they can feel a little heat when the catheter is energized.- back to top

Is it necessary to be on an anticoagulant (blood thinner) after surgery to prevent clotting?
Ambulation---walking for instance---is the recommended method to prevent clotting after most venous procedures, including Closure. The final judgement is made by the physician. However, we believe that anticoagulant therapy is not generally necessary when only the Closure procedure is performed.- back to top

Can the same Closure catheter be used on both legs?
Yes, if the same patient is treated in one session.- back to top

Can a Closure catheter be recycled?
No. Closure catheters are designed to be used once and discarded.- back to top

What potential risks and complications are associated with Closure?
Like other venous procedures, Closure involves risks and potential complications. To determine if you are a candidate and if your condition presents any special risks, you should consult your doctor. Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin burns and paresthesia.

A caution is advised if you have a pacemaker, internal defibrillator or other active implanted device; aneurismal section in the vein to be treated, or if you have documented peripheral arterial disease. Consult your physician for more information.- back to top

How long is the recovery period?
Most patients are home within hours of the procedure. The normal post operative regimen is to wear compression hose on the treated area for a few days.- back to top

How long after Closure should a patient have a follow-up visit?
Within 2-3 days.- back to top

Do insurers regard Closure as a cosmetic procedure?
It depends on the physician's diagnosis. Patients with venous disease in their saphenous veins often present with symptoms such as leg pain, leg fatigue, or swelling. There is a medical necessity to provide a therapeutic procedure for these patients and this is regularly recognized by most insurers. Treatment of leg veins in patients exhibiting only visible varicose veins with no other symptoms, and no saphenous vein incompetence is generally not reimbursed by insurance companies.- back to top

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.- back to top