Trial Results Announced for Vascular Insights ClariVein to Treat Varicose Veins
April 21, 2010—Vascular Insights LLC (Madison, CT) announced results from the initial clinical trial of its ClariVein catheter for the treatment for varicose veins. The device combines mechanical and chemical modalities to accomplish vein treatment in an in-office setting. Vascular Insights has received 510(k) clearance from the US Food and Drug Administration to market ClariVein for infusion of physician-specified agents in the peripheral vasculature. Principal investigator Steve Elias, MD, stated, “Results were excellent. The initial success rate is equal to that from radiofrequency or laser treatment of great saphenous vein disease.”
According to the company, 30 patients with an average age of 55 years were part of this first-in-man trial. Most patients had symptomatic varicose veins, with some having more advanced vein disease such as swelling and skin changes. Mean vein diameter was 8.1 mm. Treatment for each vein averaged 5 minutes and overall procedure time was 14 minutes.
At 6-month follow-up, 29 of the 30 veins treated were successfully closed. The only vein that did not respond was that of the first patient. Subsequent to the trial, 22 other patients had the ClariVein procedure, all of which were successful.
“The main advantage of this new technique in comparison to older endovenous therapies is that it does not require tumescent anesthesia infusion, saving significant time and decreasing patient discomfort,” commented Dr. Elias. “In addition, a generator is not required, and therefore capital and maintenance cost is reduced. This in-office procedure takes about 15 minutes to perform and patients resume normal activity that day, including exercise.”