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Varicose Vein Patients Recover Faster After Minimally Invasive Procedure Compared to Vein Stripping Surgery

SAN JOSE, CA -- August 1, 2003 -- VNUS Medical Technologies today announced the results of a peer reviewed, multi-center randomized trial comparing recovery rates and quality of life between patients treated with conventional varicose vein stripping surgery and radiofrequency vein ablation, (the ClosureŽ procedure). In the trial, patients receiving the Closure procedure consistently experienced less pain and returned to normal activities more than three times faster than patients whose veins were surgically stripped.

Data from the 85-patient prospective randomized study appears in the August 2003 edition of the Journal of Vascular Surgery. Patients with diseased saphenous veins at five sites in the United States, France and Austria were randomly assigned to receive either radiofrequency Closure procedure or vein stripping surgery. Follow-up evaluations were carried out at 72 hours, one week, three weeks and four months.

The study, which began in 2001, showed that 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.

"This study is important because it is the first multi-center trial to compare two similar populations of varicose vein patients who underwent different procedures," said Dr. Fedor Lurie, Director of Research for the Straub Foundation in Honolulu, HI, which has pioneered numerous vascular procedures. "The major findings are that patient quality of life scores and recovery times are significantly better after Closure than after vein stripping. For instance, 80% of the Closure patients returned to normal physical activity one day after the procedure while only 47% of the patients returned after vein stripping."

Valerie Payton's experience is typical of more than 28,000 patients who have undergone the Closure procedure. This 46-year-old mother and dance instructor began suffering from varicose veins as a teenager and her condition worsened from two pregnancies.

"With varicose veins, you get tired easily, have lots of pain, a limited range of motion and swollen legs," she said from her home in Hawaii. "It's been about two years since I had the Closure procedure, and I couldn't be happier with the results. I can teach again and attend school. I can be a cheerful mom to my kids and host dinners for 30 to 40 people in my home."

Brian Farley, President and CEO of VNUS Medical Technologies, Inc., stated, "This multi-center comparative trial is now the second randomized trial comparing radiofrequency ablation of saphenous vein reflux to vein stripping surgery. We are very pleased to see both studies confirm that patients recuperate faster with less pain and better quality of life when they receive the Closure procedure."

Varicose Veins Afflict Millions
An estimated 26 million Americans are afflicted with symptomatic varicose veins. A leading cause of this medical condition is venous reflux disease caused by leaky or "incompetent" valves in the great saphenous vein running from groin to ankle in each leg. When vein valves deteriorate, blood flows backwards in the veins (venous reflux) instead of towards the heart. This causes increased pressure in veins, which often leads to leg pain, swelling, leg fatigue, and varicose veins. Until the Closure system was developed and received clearance to market in the US in March 1999, physicians who wanted to address venous reflux and the underlying cause of symptomatic varicose veins often elected to remove or "strip" the saphenous vein. They would make an incision in the groin and a second incision below the knee or ankle, tie off the vein then remove it with a long, surgical instrument extending inside the leg to the knee. The resulting postoperative convalescence entailed a fair amount of bruising and discomfort and could last weeks. This procedure is still widely used by surgeons.

With the Closure procedure, the physician makes a single, small puncture near the knee and inserts a special catheter in the saphenous vein. The Closure catheter has a series of electrodes at the tip and a built-in temperature sensor for precise temperature monitoring. The catheter is then positioned near the groin, energized with a radiofrequency generator and slowly withdrawn, heating and sealing the vein shut. Swelling, bruising and pain are minimal in this outpatient procedure that typically lasts 45 to 60 minutes. Most patients return to normal activity within a day.


SOURCE: VNUS Medical Technologies

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