Frequently Asked Questions About Venefit™ Targeted Endovenous Therapy

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 therapy 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.

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 Venefit Therapy, there is no need for groin surgery. Instead, the vein remains in place and is closed using a special 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 Venefit Therapy is performed on an outpatient basis, typically using local or regional anesthesia.

Three randomized trials of the Venefit therapy vs. vein stripping, including the most recent multi-center comparative trial, show very similar results. In the multi-center comparative trial, Venefit Therapy was superior to vein stripping in every statistically significant outcome. In the study, 80.5% of patients treated with Venefit Therapy returned to normal activities within one day, versus 46.9% of patients who underwent vein stripping. Also, Venefit Therapy patients returned to work 7.7 days sooner than surgical patients. Patients treated with Venefit Therapy had less postoperative pain, less bruising, faster recovery and fewer overall adverse events.

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.

Venefit Therapy typically takes about 3-5 minutes, though patients normally spend 30 minutes at the medical facility due to normal pre- and post-treatment procedures.

Patients report feeling little, if any, pain during Venefit Therapy. Your physician will give you a local or regional anesthetic to numb the treatment area.

Venefit Therapy can be performed under local, regional, or general anaesthesia.

Many patients can resume normal activities immediately. For a few weeks following the treatment, your doctor may recommend a regular walking regime and suggest you refrain from very strenuous activities (heavy lifting, for example) or prolonged periods of standing. You will be asked to wear a stocking for three weeks following the procedure – during the first week the stocking should be worn all of the time (removing it for bathing) and the following two weeks just during the day (removing it for bathing and bed time).

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

Patients report minimal to no scarring, bruising, or swelling following Venefit Therapy.

As with any medical intervention, potential risks and complications exist with Venefit Therapy. All patients should consult their doctors to determine if their conditions present any special risks. Your physician will review potential complications of Venefit Therapy at the consultation, and can be reviewed in the safety summary. Potential complications can include: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia (numbness or tingling) and/or skin burn.

Only a physician call tell you if Venefit Therapy is a viable option for your vein problem. Experience has shown that many patients with superficial venous reflux disease can be treated with Venefit Therapy.

The most important step in determining whether or not Venefit Therapy 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 Venefit Therapy is appropriate for you. Venefit Therapy has been used to treat patients across a wide range of ages.

Published data suggests that two years after treatment, 90% of the treated veins remain closed and free from reflux, the underlying cause of varicose veins.

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

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

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.

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 Venefit Therapy procedure was performed.

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.

Many insurance companies are paying for the Closure procedure in part or in full. Most insurance companies determine coverage for all treatments, including Venefit Therapy, based on medical necessity. Venefit™ Targeted Endovenous Therapy has positive coverage policies with most major health insurers. Your physician can discuss your insurance coverage further at the time of consultation.

98% of patients who have undergone Venefit™ Targeted Endovenous Therapy are willing to recommend it to a friend or family member with similar leg vein problems.