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Randomized Trial Shows VNUS Closure System Produces Advantages Over Traditional Vein Stripping for Patients With Symptomatic Varicose Veins And Saphenous Vein Reflux

SAN JOSE, CA -- May 29, 2002 -- Endovenous radiofrequency obliteration of saphenous vein reflux (the Closure procedure) is associated with shorter recuperation time, less post-operative pain, faster return to normal activities, and shorter sick leaves compared to traditional vein stripping surgery according to a report in the May issue of the Journal of Vascular Surgery. This randomized trial is the first to compare endovenous obliteration of saphenous vein reflux to traditional vein stripping in the treatment of primary varicose veins.

Symptomatic Varicose Vein Disease and Treatment
A principal treatment objective for varicose vein patients with saphenous vein reflux is to eliminate the source of the venous pressure that is often the underlying cause of painful varicose veins or symptoms such as swelling, fatigue, or heaviness in the legs. The source of venous pressure is eliminated by removing the saphenous vein from circulation, allowing nearby healthy veins to return blood from the leg to the heart without reflux and the resultant venous hypertension. Traditionally the diseased saphenous vein has been removed using vein stripping involving groin surgery and typically general anesthesia. With the Closure procedure, open surgery is avoided and the treatment is routinely performed with local anesthesia and as an outpatient or doctor's office procedure.

The Closure Procedure
The Closure procedure involves a thin catheter that is inserted into a diseased vein to controllably heat the vein causing it to collapse and seal as the catheter is slowly withdrawn from the vein. The catheter is connected to a radiofrequency generator that constantly controls the vein temperature to guide effective therapeutic heating and sealing of the vein. Previously published studies have shown that two years after treatment, 90% of treated legs are free of saphenous reflux and symptoms.

Clinical Trial Results
This latest study from the Journal of Vascular Surgery is the first that directly compared the Closure procedure to vein stripping surgery. In addition to faster recuperation and less post-operative pain, patients treated with the Closure procedure experienced faster recovery of physical function than with traditional vein stripping. Almost half of the patients who received vein stripping reported pain and tension in their thigh two weeks after surgery, resulting in disturbed walking, delayed recovery, and longer sick leave compared to the Closure procedure. Longer sick leave is especially relevant since in this study 96% of patients were actively employed. Lead investigator, Tero Rautio, MD of the Department of Surgery at Oulu University Hospital in Finland, commented, "We observed that patients who received the Closure procedure were able to resume normal daily activities faster and were very satisfied with the outcome." Dr. Rautio concluded from his study that the Closure procedure may potentially replace conventional varicose vein surgery.

Brian Farley, VNUS' President and Chief Executive Officer pointed out, "This prospective randomized trial was performed without any involvement or support of VNUS Medical Technologies. We are pleased the Closure procedure generated positive clinical outcomes compared to vein stripping and that this trial independently demonstrated many of the patient benefits produced by the Closure procedure."

About VNUS Medical Technologies, Inc.
VNUS Medical Technologies, founded in 1995, is a world leader in the development and commercialization of products for minimally invasive treatment of venous disease. The company currently markets the proprietary Closure System of products for patients who suffer from symptoms associated with venous reflux. The Closure system was cleared for marketing in the U.S. in March 1999. Since then, over 12,000 patients have received the Closure procedure and numerous studies have shown the Closure procedure provides substantial benefits to patients. Many health insurance plans in the U.S. now cover the procedure for their members. For more information please visit the company's web site at http://www.vnus.com.


SOURCE: VNUS Medical Technologies, Inc.

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