QUESTIONS & ANSWERS: The Closure^® Procedure

Q1) What is superficial venous reflux?
Q2) What is the VNUS Closure procedure?
Q3) How does the VNUS Closure procedure treat superficial venous reflux?
Q4) How is the VNUS Closure procedure different from vein stripping?
Q5) Is the VNUS Closure procedure painful?
Q6) Does the VNUS Closure procedure require anesthesia?
Q7) How quickly after treatment can I return to normal activities?
Q8) How soon after treatment will my symptoms improve?
Q9) Is there any scarring, bruising, or swelling after the VNUS Closure procedure?
Q10) What risks and complications are associated with the VNUS Closure
          procedure?
Q11) Is the VNUS Closure procedure suitable for everyone?
Q12) Is age an important consideration for the VNUS Closure procedure?
Q13) What happens to the treated vein left behind in the leg?
Q14) Is the VNUS Closure procedure covered by insurance or Medicare?

QUESTIONS & ANSWERS:Venous Disease

Q15) What are varicose veins?
Q16) What causes varicose veins?
Q17) Why does it usually occur in the legs?
Q18) Who is at risk for varicose veins?
Q19) What are the symptoms?
Q20) What are venous leg ulcers?
Q21) What is the short term treatment for varicose veins?
Q22) What is sclerotherapy?
Q23) What is ambulatory phlebectomy?
Q24) What is vein stripping?
Q25) When is the VNUS Closure procedure used?
Q26) What is the main difference between arteries and veins?
Q27) What are the three main categories of veins?

QUESTIONS & ANSWERS: The Closure Procedure

Q1) What is superficial venous reflux?
A) Superficial venous reflux is a condition that develops when the valves that usually keep blood flowing out of your legs become damaged or diseased. This causes blood to pool in your legs. Common symptoms of superficial venous reflux include pain, swelling, leg heaviness and fatigue, as well as varicose vein in your legs.


Q2) What is the VNUS Closure procedure?
A) The Closure procedure is a minimally invasive treatment for superficial venous reflux. A thin catheter is inserted into the vein through a small opening. The catheter delivers thermal energy to the vein wall, causing it to heat, collapse, and seal shut.


Q3) How does the VNUS Closure procedure treat superficial venous reflux?
A) Since valves can't be repaired, the only alternative is to re-route blood flow through healthy veins. Traditionally, this has been done by surgically removing (stripping) the troublesome vein from your leg. The Closure procedure provides a less invasive alternative to vein stripping by simply closing the problem vein instead. Once the diseased vein is closed, other healthy veins take over and empty blood from your legs.



Q4) How is the VNUS Closure procedure different from vein stripping?
A) During a stripping procedure, the surgeon makes an incision in your groin and ties off the vein, after which a stripper tool is threaded through the saphenous vein and used to pull the vein out of your leg through a second incision just above your calf. In the Closure procedure, there is no need for groin surgery. Instead, the vein remains in place and is closed using a special (Closure) catheter inserted through a small puncture. This may eliminate the bruising and pain often associated with vein stripping (i.e., that may result from the tearing of side branch veins while the saphenous vein is pulled out). Vein stripping is usually performed in an operating room, under a general anesthetic, while the Closure procedure is performed on an outpatient basis, typically using local or regional anesthesia.


Q5) Is the VNUS Closure procedure painful?
A) Although some people are more sensitive than others, patients generally report little pain. Some have said they can feel a little heat when the catheter is energized.


Q6) Does the VNUS Closure procedure require anesthesia?
A) The Closure procedure can be performed under local, regional, or general anesthesia.


Q7) How quickly after treatment can I return to normal activities?
A) Many patients typically return to normal activities within a day.1 For a few weeks following the treatment, your doctor may recommend a regular walking regimen and suggest you refrain from very strenuous activities (heavy lifting, for example) or prolonged periods of standing.

(Note: These results were obtained using VNUS Closure and VNUS ClosurePlus; RF products with expandable extrodes)


Q8) How soon after treatment will my symptoms improve?
A) Most patients report a noticeable improvement in their symptoms within 1-2 weeks following the procedure.

Q9) Is there any scarring, bruising, or swelling after the VNUS Closure procedure?
A) Patients report minimal to no scarring, bruising, or swelling following the Closure procedure.


Q10) What risks and complications are associated with the VNUS Closure procedure?
A) As with any medical intervention, potential risks and complications exist with the Closure procedure. All patients should consult their doctors to determine if their conditions present any special risks. Your physician will review potential complications of the Closure procedure at the consultation, and can be reviewed in the safety summary. Potential complications can include: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, adjacent nerve injury (tingling or numbness) and/or skin burn.



Q11) Is the VNUS Closure procedure suitable for everyone?
A) Only a physician call tell you if the Closure procedure is a viable option for your vein problem. Experience has shown that many patients with superficial venous reflux disease can be treated with the Closure procedure.


Q12) Is age an important consideration for the VNUS Closure procedure?
A) The most important step in determining whether or not the Closure procedure is appropriate for you is a complete ultrasound examination by your physician or qualified clinician. Age alone is not a factor in determining whether or not the Closure procedure is appropriate for you. The Closure procedure has been used to treat patients across a wide range of ages.^3,4,5


Q13) What happens to the treated vein left behind in the leg?
A) The vein simply becomes fibrous tissue after treatment. Over time, the vein will gradually incorporate into surrounding tissue.


Q14) Is the VNUS Closure procedure covered by insurance or Medicare?
A) Many insurance companies are paying for the Closure procedure in part or in full. Most insurance companies determine coverage for all treatments, including the Closure procedure, based on medical necessity. The VNUS^� Closure procedure has positive coverage policies with most major health insurers. Your physician can discuss your insurance coverage further at the time of consultation.

QUESTIONS & ANSWERS:Venous Disease

Q15) What are varicose veins?
A) Varicose veins--which afflict 10% to 20% of all adults --are swollen, twisted, blue veins that are close to the surface of the skin. Because valves in them are damaged, they hold more blood at higher pressure than normal. That forces fluid into the surrounding tissue, making the affected leg swell and feel heavy.


Unsightly and uncomfortable, varicose leg veins can promote swelling in the ankles and feet and itching of the skin. They may occur in almost any part of the leg but are most often seen in the back of the calf or on the inside of the leg between the groin and the ankle. Left untreated, patient symptoms are likely to worsen with some possibly leading to venous ulceration.



Q16) What causes varicose veins?
A)The normal function of leg veins - both the deep veins in the leg and the superficial veins - is to carry blood back to the heart. During walking, for instance, the calf muscle acts as a pump, contracting veins and forcing blood back to the heart.

To prevent blood from flowing in the wrong direction, veins have numerous valves. If the valves fail (a cause of venous reflux), blood flows back into superficial veins and back down the leg. This results in veins enlarging and becoming varicose. The process is like blowing air into a balloon without letting the air flow out again- the balloon swells.

To succeed, treatment must stop this reverse flow at the highest site or sites of valve failure. In the legs, veins close to the surface of the skin drain into larger veins, such as the saphenous vein, which run up to the groin. Damaged valves in the saphenous vein are often the cause of reversed blood flow back down into the surface veins.


Q17) Why does it occur more in the legs?
A)Gravity is the culprit. The distance from the feet to the heart is the furthest blood has to travel in the body. Consequently, those vessels experience a great deal of pressure. If vein valves can't handle it, the backflow of blood can cause the surface veins to become swollen and distorted.


Q18) Who is at risk for varicose veins?
A) Conditions contributing to varicose vein include genetics, obesity, pregnancy, hormonal changes at menopause, work or hobbies requiring extended standing, and past vein diseases such as thrombophlebitis (i.e. inflammation of a vein as a blood clot forms.) Women suffer from varicose vein more than men, and the incidence increases to 50% of people over age 50.


Q19) What are the symptoms?
A) Varicose veins may ache, and feet and ankles may swell towards day's end, especially in hot weather. Varicose veins can get sore and inflamed, causing redness of the skin around them. In some cases, patients may develop venous ulcerations.


Q20) What are venous leg ulcers?
A)Venous ulcers are areas of the lower leg where the skin has died and exposed the flesh beneath. Ulcers can range from the size of a penny to completely encircling the leg. They are painful, odorous open wounds which weep fluid and can last for months or even years. Most leg ulcers occur when vein disease is left untreated. They are most common among older people but can also affect individuals as young as 18.


Q21) What is the short term treatment for varicose veins?
A)ESES (pronounced SS) is an easy way to remember the conservative approach. It stands for Exercise Stockings Elevation and Still. Exercising, wearing compression hose, elevating and resting the legs will not make the veins go away or necessarily prevent them from worsening because the underlying disease (venous reflux) has not been addressed. However, it may provide some symptomatic relief. Weight reduction is also helpful.

If there are inflamed areas or an infection, topical antibiotics may be prescribed. If ulcers develop, medication and dressings should be changed regularly.

There are also potentially longer-term treatment alternatives for visible varicose vein, such as sclerotherapy and phlebectomy.



Q22) What is sclerotherapy?
A)A chemical injection, such as a saline or detergent solution, is injected into a vein causing it to "spasm" or close up. Other veins then take over its work. This may bring only temporary success and varicose vein frequently recur. It is most effective on smaller surface veins, less than 1-2mm in diameter.


Q23) What is ambulatory phlebectomy?
A)As with sclerotherapy, ambulatory phlebectomy is a surgical procedure for treating surface veins in which multiple small incisions are made along a varicose vein and it is "fished out" of the leg using surgical hooks or forceps. The procedure is done under local or regional anesthesia, in an operating room or an office "procedure room."


Q24) What is vein stripping?
A)If the source of the reverse blood flow is due to damaged valves in the saphenous vein, the vein may be removed by a surgical procedure known as vein stripping. Under general anesthesia, all or part of the vein is tied off and pulled out. The legs are bandaged after the surgery but swelling and bruising may last for weeks.


Q25) When is Closure used?
A)Closure is used, like vein stripping, to eliminate reverse blood flow in the saphenous vein, but without physically removing the vein, and can be performed without general anesthesia. Like other venous procedures, the Closure procedure involves risks and potential complications. Each patient should consult their doctor to determine whether or not they are a candidate for this procedure, and if their condition presents any special risks. Complications reported in medical literature include numbness or tingling (paresthesia) skin burns, blood clots, temporary tenderness in the treated limb.


Q26) What is the main difference between arteries and veins?
In simplest terms, arteries pump oxygen-rich blood FROM the heart, veins return oxygen-depleted blood TO the heart.


Q27) What are the three main categories of veins?
A) Deep leg veins return blood directly to the heart and are in the center of the leg, near the bones. Superficial leg veins are just beneath the skin. They have less support from surrounding muscles and bones than the deep veins and may thus develop an area of weakness in the wall. When ballooning of the vein occurs, the vein becomes varicose. Perforator veins serve as connections between the superficial system and the deep system of leg veins.



¹ Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, et al. Prospective randomized study of endovenous radiofrequency obliteration (Closure) versus ligation and stripping in a selected patient population (EVOLVES study). J Vasc Surg 2003;38:207-14.

² Goldman, H. Closure of the greater saphenous vein with endo radiofrequency thermal heating of the vein wall in combination with ambulatory phlebectomy: preliminary 6-month follow-up. Dermatology Surg 2000; 26:452-456.

³ Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg 2002;35:1190-6.

^4&7 Weiss RA, et al. Controlled Radiofrequency Endovenous Occlusion Using a Unique Radiofrequency Catheter Under Duplex Guidance to Eliminate Saphenous Varicose Vein Reflux: A 2-Year Follow-up, Dermatologic Surgery, Jan 2002; 28:1: 38-42

⁵ Whiteley, MS, Holstock JM, Price BA, Scott MJ, Gallagher TM. Radiofrequency Ablation of Refluxing Great Saphenous Systems, Giacomini Veins, and Incompetent Perforating Veins using VNUS Closure and TRLOP technique. Abstract from Journal of Endovascular Therapy 2003; 10:I-46.

⁶ Pichot O, Sessa C, Chandler JG, Nuta M, Perrin M. Role of duplex imaging in endovenous obliteration for primary venous insufficiency. J. Endovasc Ther 2000;7:451-9.

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