ClariVein® Catheter for Varicose Veins: Clinical Trial Final Results Announced
By Mel Fabrikant Friday, April 30, 2010, 07:37 PM EDT
Dr. Steve Elias
Elias, The Leader in Treating Venous Disease
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.
“The main advantage of this new technique in comparison to older endovenous therapies,” Dr. Elias said, “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.”
Steve Elias MD FACS FACPh, is Associate Professor of Surgery at Mount Sinai Hospital, NY and the Director of The Centers for Vein Disease at Mount Sinai and Englewood Hospitals.
The ClariVein® catheter is a product of Vascular Insights LLC (http://vascularinsights.com) <http://vascularinsights.com%29> of Madison, CT. The company engages in the design, development, manufacture, and marketing of medical devices for the minimally invasive treatment of peripheral vascular disease.
Vascular Insights has received 510(k) clearance from the U.S. Food and Drug Administration (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.
Photos of the device can be downloaded from <http://vascularinsights.com/devicepix4-complete.htm> or for more information log on to www.veindisease.com
For more information about Dr. Elias or to set up an interview please contact Angela Thomas at (201)-503-1333.
About Steve Elias, MD, FACS
Director, Center for Vein Disease
Mount Sinai School of Medicine NY
Director, Center for Vein Disease
Englewood Hospital and Medical Center NJ
Steve Elias is the Director of The Centers for Vein Disease at Manhattan’s Mount Sinai Medical Center and at Englewood Hospital and Medical Center in New Jersey is Board Certified in both Phlebology and Surgery. Dr. Steve Elias was recently named by Vein Magazine as one of the 25 most influential professionals in vein care worldwide and Voted “Best Doctor” in 2009 by New York Magazine. Dr. Elias lectures, publishes, and teaches extensively about minimally invasive vein care and procedures. As Course Director of the Annual Vascular Fellows Course in Venous Disease, he trains young vascular surgeons in the treatment of vein problems. His clinical interests encompass all aspects of vein care: spider veins, varicose veins, perforator and deep venous incompetence, and venous ulcers. He performs all minimally invasive vein procedures and his work at the Center for Vein Disease includes the prevention and treatment of DVT Deep Venous Thrombosis. Dr. Elias is a fellowship-trained vascular surgeon and member of the American Venous Forum, the American College of Phlebology, the Society for Clinical Vascular Surgery, and the International Society of Cardiovascular Surgery. He is a recipient of the Dardik Research and Education Award.
