The VNUS® Closure procedure, an alternative treatment option to traditional vein stripping surgery, brings state-of-the-art technology to an age-old disease.

The Closure procedure is performed on an outpatient basis. Using ultrasound, your physician will position the Closure catheter into the diseased vein, through a small opening in the skin. The tiny catheter delivers radiofrequency (RF) energy to the vein wall. As the RF energy is delivered and the catheter is withdrawn, the vein wall is heated, causing the collagen in the wall to shrink and the vein to close. Once the diseased vein is closed, blood is re-routed to other healthy veins.

Following the procedure, a simple bandage is placed over the insertion site, and additional compression may be provided to aid healing. Your doctor may encourage you to walk, and to refrain from extended standing and strenuous activities for a period of time.

Patients who undergo the Closure procedure typically resume normal activities within a day.

VNUS Closure® Procedure Brochure: HTML Version PDF Version

The Closure® Procedure -- A Treatment That Works

Clinical results indicate that the Closure procedure can be effective at closing the vein and significantly reducing patient symptoms.

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

At two years following treatment, patients who had undergone the Closure procedure reported superior quality of life compared to vein stripping patients.¹

The Closure procedure has proven to be highly effective, with 87% of veins treated remaining closed at 5 years.² Results also demonstrate long-term relief of symptoms.²

Patient Symptoms Reported at Follow-up:²

Three randomized trials of the Closure procedure versus vein stripping, including the multi-center comparative trial published August 2003 in the Journal of Vascular Surgery, show very similar results.^2,3,4 In the most recent trial every statistically significant outcome was in favor of the Closure procedure, resulting in¹:

• Experienced less post-operative pain and bruising
• Resumed normal activities within one day
• Returned to work more than a week earlier than vein stripping patients

Visual Results

Before Treatment

After Treatment

Percent of Legs without Varicose Veins at Follow-up
The Closure procedure is shown to be effective as vein stripping in delaying the reappearance of varicose veins:

Treatment	1 Year	2 Years
Closure6	90%	87%
Vein Stripping7	86%	75%
Ligation7	86%	57%

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 Merchant RF, et al. J Vasc Surg 2005; 42: 502-9
³ Stötter L. Schaaf I, Fendl R, Bockelbrink A. Randomized Study to Compare the Closure Procedure, Invagination Stripping and Cryo Stripping for Treatment of the Greater Saphenous Vein. Abstract submitted to German Society for Phlebology for presentation Sept. 2003.
⁴ Rautio T, Ohinmaa A, Perälä J, Ohtonen P, Heikkinen T, Wiik H, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized controlled trial with comparison of costs. J Vasc Surg 2002;35:958-65.
⁵ Photos Courtesy of Michael A. Vasquez, MD.
⁶ Merchant RF, DePalma RG, Kabnick LS. Endovascular Obliteration of Saphenous Reflux: A Multicenter Study. J Vasc Surg 2002;35:1190-6.
⁷ Jones L et al. Neovascularisation is the Principal Cause of Varicose Vein Recurrence: Results of a Randomized Trial Of Stripping The Long Saphenous Vein. Eur J Vasc Endovasc Surg 1996;12:442-445

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QUESTIONS & ANSWERS: The Closure® procedure

What is superficial venous reflux?

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 veins in your legs.

What is the Closure procedure?

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.

How does it work to treat superficial venous reflux?

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.

How is the Closure procedure different from vein stripping?

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.

Is the Closure procedure painful? 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.

Will the procedure require any anesthesia?

The Closure procedure can be performed under local, regional, or general anesthesia.

How quickly after treatment can I return to normal activities?

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)

How soon after treatment will my symptoms improve?

Most patients report a noticeable improvement in their symptoms within 1-2 weeks following the procedure.

Is there any scarring, bruising, or swelling after the Closure procedure?

Patients report minimal to no scarring, bruising, or swelling following the Closure procedure.

Are there any potential risks and complications associated with the Closure procedure?

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.

Is the Closure procedure suitable for everyone?

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.

Is age an important consideration for the Closure procedure?

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.

What happens to the treated vein left behind in the leg?

The vein simply becomes fibrous tissue after treatment. Over time, the vein will gradually incorporate into surrounding tissue.

Is the Closure treatment covered by my insurance?

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.

Introducing the VNUS ClosureFAST^TM Catheter

As leaders in the treatment of venous disease, Triangle Vein Clinic is in the forefront of technology. Consequently, when VNUS Medical Technologies, Inc. first introduced the ClosureFAST Catheter, Triangle Vein Clinic was one of six national--and only North Carolina--site(s) to participate in the initial trial.

Our facility is proud to announce the availability of the VNUS ClosureFAST^TM catheter.

The new generation VNUS ClosureFAST catheter was introduced and received FDA clearance in August 2006 and is a culmination of approximately four years of research and development. The ClosureFAST catheter is designed to significantly reduce procedure time and enhance ease-of-use for the physician. Like the original VNUS Closure catheter, the ClosureFAST catheter uses RF energy and VNUS RF generators to deliver controlled energy and monitor treatment temperature for the purpose of closing diseased veins. The Closure procedure using the ClosureFAST catheter minimizes the post-procedure pain and bruising commonly associated with the competitive endovenous laser treatment.

Safety Summary

As with any medical procedure, the Closure® procedure is not suitable for all people and there are associated risks and considerations. You should consult your physician to determine if the Closure procedure is right for you, and to discuss any special risks your individual condition may present.

The Closure System is intended for endovascular coagulation of blood vessels in patients with superficial venous reflux.

Patients with thrombus in the vein segment to be treated.

PRECAUTION: For patients with a pacemaker, internal defibrillator or other active implanted device, consult the cardiologist and the manufacturer of the active implanted device. Continuous patient monitoring during the procedure is recommended. Evaluate the patient and the implanted active device post procedure. Keep all power cords and the attached sterile cable away from the location of the pacemaker or leads, defibrillator or the implanted active device.

CAUTION: In patients with an aneurysm in the vein segment to be treated, the vein wall may be thinner in the area of the aneurysm. To effectively occlude a vein with an aneurysmal segment, additional tumescent infiltration may be needed over the aneurysmal segment, and the treatment of the vein should include segments proximal and distal to the aneurysmal segment.

CAUTION: No data exists regarding the use of this catheter in patients with documented peripheral arterial disease. The same care should be taken in the treatment of patients with significant peripheral arterial disease as would be taken with a traditional vein ligation and stripping procedure.

• Potential complications include, but are not limited to, the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, adjacent nerve injury, skin burns.
• Treatment of veins located very close to the skin surface may result in a skin burn.
• Adjacent nerve injury is higher with treatment at or below the calf.

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VeinGogh Procedure

Are you one of millions who suffer from embarrassing spider veins, red spots or redness on your cheeks and nose? Well, there is finally an effective, dependable treatment for your condition--VeinGogh.

Telangectasia is a very common problem that develops from a range of factors, including age, hereditary, lifestyle and diet. These unsightly blemishes can appear on several visible areas including cheeks, chin, nose, ankles, knees and inner thighs. VeinGogh is the newest technology available for treating these benign vascular abnormalities.

The VeinGogh Ohmic Thermolysis System generates a tiny, regulated, high frequency current delivered to the vessel via a hair-thin probe. A "microburst" of energy selectively heats the vein, coagulating the blood and collapsing the vessel wall, which is quickly absorbed into the body. All this is accomplished without affecting the outer layers of the skin resulting in a quick return to normal daily activities.

View interactive VeinGogh Brochure