Endovenous RadioFrequency Ablation (Closure Procedure)
Varicose Vein Overview
If you suffer from varicose veins, you’re a member of a very large club. Some 25 million Americans face a daily struggle with the swollen, ropey veins that can cause throbbing pain, severe swelling, and heavy, tired legs.
Half of all Americans over 50, and two-thirds of women over 60, have the condition. And many have dealt with it for decades, because varicose veins can appear even in teenagers too young to vote.
Heredity is a factor in venous reflux disease – if your parents or siblings have had varicose veins, you're more likely to develop them – and people who are obese or have had multiple pregnancies are particularly susceptible, because the extra weight adds strain to the veins. Women are more vulnerable to the problem than men, partly because the hormonal changes brought on by menstruation, menopause and hormone-based drug therapy can relax vein walls and cause venous reflux.
Your lifestyle, particularly physical activity, can affect your odds of developing varicose veins as well. People whose careers require them to stand in place for long periods of time – nurses, teachers, waitresses, flight attendants and other service personnel, for example – have a higher-than-average risk of venous disease. So do people who do a good deal of heavy lifting.
Once it appears, venous reflux disease never goes away by itself – it's a progressive condition that can only worsen unless treated. Fortunately, the minimally-invasive, device-based advances in medical technology that have so profoundly impacted heart, lung and brain surgery in recent years are now having a similarly revolutionary impact on the treatment of varicose veins. The next-generation VNUS ClosureFAST™ catheter represents the cutting edge of that technology.
VNUS Closure Procedure
The VNUS Closure procedure is a minimally invasive treatment alternative with less pain and less bruising when compared to traditional vein stripping surgery and laser treatment. Using the Closure system, physicians close the diseased veins by inserting the Closure catheter into a vein and heating the vein wall using temperature-controlled RF energy. Heating the vein wall causes collagen in the wall to shrink and the vein to close. After the vein is sealed shut, blood then naturally reroutes to healthy veins.
Venous reflux or venous insufficiency develops when the valves that usually keep blood flowing out of your legs become damaged or diseased.
The Closure procedure provides the following benefits for patients and physicians:
- Minimally Invasive Outpatient Procedure. Closure catheters are inserted into the vein via a tiny incision in the lower leg, eliminating the need for groin surgery and general anesthesia. The Closure procedure can be performed using local anesthesia in a physician’s office, as well as in an outpatient hospital setting or surgery center.
- Clinically Proven Less Post-Operative Pain. The Closure procedure does not involve pulling the diseased vein from the thigh as with vein stripping surgery, or using 700° C laser energy which boils blood to occlude a vein as with endovenous laser (EVL)12. In the RECOVERY Trial, a multi-center head-to-head comparative randomized trial comparing the Closure procedure with EVL, the Closure procedure was found to have less patient pain and less patient bruising than EVL for the best patient recovery experience available from a minimally invasive vein treatment.10 Additionally, in other randomized comparative studies have shown that patients receiving the Closure procedure return to normal activity and work significantly faster than those receiving vein stripping.3
- Excellent Clinical Outcomes. The ClosureFAST catheter, which represents the latest advancement in the Closure procedure, has been shown in a multi-center study to have a 97.4 efficacy rate at one-year.11 This shows that the treatment is highly effective and, as proven in the RECOVERY trial, is gentle on the patient.10
- Cosmetically Appealing. Because treatment with Closure is minimally invasive and is catheter-based, it results in little to no scarring. As with any medical procedure, you are encouraged to review all safety information associated with the procedure by consulting your physician.
Comparing Treatment Options
||The VNUS Closure™ Procedure
||Vein Stripping & Legation
|Method of action
||Collagen contraction resulting in a fibrotic seal
||Boiling of blood resulting in a thrombotic occlusion
||97.4% closure at 1 year
||No multi-center studies
|Return to normal activities within 24 hours
||89.1% of patients
||69.8% of patients
|80.5% of patients
||46.9% of patients
What is Radiofrequency Ablation?
Radiofrequency (RF) endovenous ablation is a minimally invasive treatment procedure for venous reflux disease, using radiofrequency to heat and seal diseased great saphenous and perforator veins and address the underlying cause of severe varicose veins. The VNUS ClosureFAST™ catheter for the treatment of venous reflux delivers radiofrequency energy to a heating element to heat and contract the collagen within the vein walls and cause the shrinkage and collapse of the vessel.
The procedure involves inserting the catheter into the diseased vein through a very small incision and threading the device through the vessel up to the groin area. Radiofrequency waves are applied to the heating element in 20-second intervals to sequentially heat and ablate the vein in seven centimeter increments. After each segment is treated, the ClosureFAST catheter is manually withdrawn down the vein and the process is repeated until the entire length of the vein has been ablated. The body automatically re-routes blood flow through healthier veins, and the restoration of normal circulation relieves the distention of the surface veins. The ablated vein becomes scar tissue and is eventually absorbed by the body.
Clinical Trial Results
Treat your varicose veins with:
- Less Pain
- Less Bruising
- Fewer Complication
Ask for The VNUS Closure™ Procedure
In a head-to-head trial versus laser, the Closure Procedure provided the Best Patient Recovery Experience.
What is the Difference Between Varicose Veins and Spider Veins?
Varicose veins and spider veins are both visible surface symptoms of venous insufficiency, the inability of diseased leg veins to push blood back up towards the heart. The surface veins become distended and prominent because blood that should normally circulate through the body is instead accumulating in the legs.
Varicose veins are a medical condition, larger and more serious manifestations of venous reflux disease. The swollen vessels can protrude several millimeters beyond the skin surface and can become knotted and tangled. Varicose veins are frequently accompanied by clinical symptoms such as pain, throbbing, burning sensations, muscle cramps and fatigue, and can progress to leg ulcers, blood clots and other health-endangering conditions.
|Spider veins are thin surface veins that turn blue or red under the strain of the venous reflux and affect the appearance of the location where they occur. Spider veins are considered a cosmetic problem, rarely causing physical discomfort, and can be addressed with a variety of non-invasive, techniques.
Frequently Asked Questions
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 radiofrequency (RF) 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.
Three randomized trials of the Closure procedure vs. vein stripping, including the most recent multi-center comparative trial, show very similar results. In the multi-center comparative trial, the Closure procedure was superior to vein stripping in every statistically significant outcome. In the study, 80.5% of patients treated with the Closure procedure returned to normal activities within one day, versus 46.9% of patients who underwent vein stripping. Also, Closure patients returned to work 7.7 days sooner than surgical patients. Patients treated with the Closure procedure had less postoperative pain, less bruising, faster recovery and fewer overall adverse events.
How long does the Closure procedure take?
- The Closure procedure takes approximately 45-60 minutes, though patients normally spend 2-3 hours at the medical facility due to normal pre- and post-treatment procedures.
Is the Closure procedure painful?
- Patients report feeling little, if any, pain during the Closure procedure. Your physician will give you a local or regional anesthetic to numb the treatment area.
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 can resume normal activities immediately.2 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.
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.
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.
How effective is the Closure procedure?
- Data from a prospective multi center study have shown 97.4% vein occlusion 1 year post-treatment.
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. One study reported that 89% of treated veins are indistinguishable from other body tissue one year after the Closure procedure was performed.
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.
What are patients saying about the Closure procedure?
- 98% of patients who have undergone the Closure procedure are willing to recommend it to a friend or family member with similar leg vein problems.
Click here for Endovenous Ablation Closure Procedure Before and After Photos