Vascular Insights, a developer, manufacturer and marketer of cardiovascular medical devices, has presented final results of the initial clinical trial of the ClariVein catheter, used in a new minimally invasive treatment for varicose veins.
A product of Vascular Insights, ClariVein catheter combines mechanical and chemical modalities to accomplish vein treatment in an in-office setting.
According to the study, 30 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.
Vascular Insights said that in the study, 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.
Vascular Insights has received 510(k) clearance from the FDA to market ClariVein for infusion of physician-specified agents in the peripheral vasculature. The company holds certification from BSI (the British Standards Institution) that the design, development, manufacture, and distribution of the ClariVein device comply with the requirements of ISO 13485: 2003.
Steve Elias, principal investigator of IRB-regulated trial conducted at Englewood Hospital and Medical Center and associate professor of surgery at Mount Sinai Hospital, NJ, said: “Results were excellent. The initial success rate is equal to that from radiofrequency or laser treatment of great saphenous vein disease.
“The main advantage of the new technique in comparison to older endovenous therapies is that it does not require tumescence anesthesia infusion, saving significant time and decreasing patient discomfort. 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. All patients would recommend the procedure to others.”