Results from the initial clinical trial of the ClariVein® catheter, used in a new minimally invasive treatment for varicose veins, have been announced. The device combines mechanical and chemical modalities to accomplish vein treatment in an in-office setting.
Steve Elias MD FACS FACPh was the principal investigator of this IRB-regulated trial conducted at Englewood Hospital and Medical Center, NJ. “Results were excellent,” Dr. Elias stated. “The initial success rate is equal to that from radiofrequency or laser treatment of great saphenous vein disease.”
Thirty patients with an average age of 55 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 six-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, to date 22 other patients have had the ClariVein® procedure, with all being successful.
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