QUESTIONS & ANSWERS: THE CLOSURE® SYSTEM

What is the Closure® procedure?
A minimally-invasive surgical procedure that uses radiofrequency energy to occlude, or close, the saphenous vein running down the inside of the leg. The Closure® System received commercial clearance in the U.S. in March 1999.

Does it work?
Yes. In extensive clinical tests involving thousands of patients conducted in Europe and the United States, Vnus Medical Technologies has demonstrated that the Closure® system is effective at occluding varicose veins and significantly reducing patient symptoms.

How does it work?
The Closure® catheter delivers bipolar radio frequency energy directly into the vein wall. The passage of energy through the vein wall causes heating which denatures protein and shrinks the vessel. The Closure® catheters flexible electrodes cause the vessel to collapse, closing the vein and eliminating reflux. This reduces pressure throughout the entire surface vein system.

What are the patient benefits?
Unlike vein stripping, the Closure® procedure is minimally invasive and lets most patients walk out of the medical facility within hours. Closure® quickly normalizes venous blood pressure in a treated leg. This typically results in a reduction or elimination of pain and swelling associated with varicose veins. Convalescence from Closure® as described is usually a couple of days in contrast to vein stripping, which can take weeks and involve significant pain.

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® "normalizes" the pressure in leg veins, the skin and veins may not always stretch back like healthy, elastic tissue when the pressure is reduced. In such cases, physicians typically 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 appears to be no more than 10% at one year.

What patients can be treated?
That decision rests with individual physicians. Electrodes on the Closure® catheter expand to 12mm. Vein diameters from 2-12mm can thus be treated successfully. (Measurements are taken with duplex ultrasound.)

Is Closure® available in the United States?
The Closure® system received commercial clearance in the US in March 1999 and although limited, it is available in major metropolitan centers worldwide..

What does the procedure cost?
The cost of this procedure 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 within a day or two. Therefore, the cost in lost productivity from work is greatly reduced, with this savings passed on directly to the consumer..

Does Closure® require an operating room?
As with any surgical procedure, this requires a dedicated operating room or office procedure room. This choice is often dictated by the patients insurance. We have capability for both in-hospital or in office procedures and can prioritize the patients comfort either way.

How long does the procedure take?
Approximately 1 hours 45 minutes, though plan to spend 2-3 hours at the medical facility for check-in and observation following the procedure.

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 in the same leg during a single operation. This can decrease the need for multiple staged operations. 

Does it hurt?
Although some people are more sensitive than others, few patients complain of pain. Most patients' procedures are done while they are slightly sedated. While lightly sedated, local anesthetic is also placed so that the patient feels nothing.  In fact, patients remain comfortable, even as they wake up, and report no recollection of any part of the procedure.

Is it necessary to be on an anticoagulant after surgery to prevent clotting?
No. Ambulation--- walking, for instance-- is the recommended method to prevent clotting after most venous procedures, including Closure®.

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

How long is the recovery period?
Most patients are home within 2 hours of the procedure. The normal procedure is to wear a compression ace-wrap on the treated leg for a few days.

How long after Closure® should a patient have a follow-up visit?
Within 2-3 days for an ultrasound and 2 weeks for a wound check.

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

The Closure® procedure is new enough that insurers are just now becoming aware of it. Clinical studies have shown that this new, minimally invasive manner of treating leg veins can be done in a way that produces excellent clinical outcomes with minimal trauma and recuperation time for the patient. Patient satisfaction rates have been greater than 90%.

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 as a first choice. The Radial artery from the arm can also be used as a second alternative. Remember a diseased, varicose saphenous vein is not a good option to revascularize your heart.


Which patients are not considered good candidates for the Closure® procedure?
Each patient should consult with their doctor for a final determination. The follow-ng people are not considered candidates for Closure® procedure.
Patients with a pacemaker or internal defibrillator;
Patients with significant peripheral artery disease.
Patients with poorly controlled diabetes
Patients with significant medical problems precluding safe surgery or anesthesia
Patients who are morbidly obese.

What potential risks and complications are associated with Closure®?
Like any surgical procedure, Closure® involves potential complications. Complications include but are not limited to: post operative pain, numbness, bleeding, infection, anesthetic risks, injury to nearby structures such as skin, nerves, blood vessels,) and blood clots. These events are extremely rare, and in fact a procedure like Closure® such risk is much less than the risk assumed when you get in your car and drive in to your appointment.

To determine if they are a candidate and if their condition presents any special risks, each patient should consult with me.

Closure® is a Registered Trademark of VNUS Medical Technologies