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 July 2003, more than 28,000 Closure procedures have been performed worldwide. 

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.  

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  The passage of heat through the vein wall as the catheter is withdrawn causes resistive heating which shrinks the vessel.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

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. 

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. 

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 at the time the Closure procedure is done.  

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.  

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.   

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. 

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

What does the procedure cost?
The overall procedure cost, often covered by medical insurance, is comparable to vein stripping, which currently ranges from $2,000-$4,000 per leg.  However, after a 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. 

Is Closure covered by insurance?
Many national and regional insurance carriers have issued positive coverage policy for the Closure procedure and are covering the procedure in part or in full.  Your Closure physician can discuss cost, insurance coverage, etc in greater detail during your consultation visit.   

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. Showing the medical necessity of the procedure is required 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. 

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

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

How long does the procedure take?
Approximately 45-60 minutes, though patients normally spend 2-3 hours at the medical facility due to normal pre and post-treatment procedures.

 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.  

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.  

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.  

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. 

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

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. 

Which patients are not considered good candidates for the Closure procedure?
Each patient should consult with their doctor for a final determination.  Patients with thrombus in the vein segment to be treated are not considered candidates for the Closure procedure. 

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

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

Can a Closure catheter be reused? 
No.  Closure catheters are single use disposable devices.

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