The results of the initial clinical trial of the ClariVeinTM catheter, used in a new minimally invasive treatment for varicose veins, were delivered on Wednesday, September 2, at the XVIth World Meeting of the Union Internationale de Phlebologie in Monaco. The device combines mechanical and chemical modalities to accomplish vein treatment in an in-office setting.

Speaking was Steve Elias MD FACS FACPh, Associate Professor of Clinical Surgery at Manhattan's Mount Sinani School of Medicine and the Director of The Centers for Vein Disease at Columbia University Medical Center and Englewood Hospitals. Dr. Elias is the principle investigator of the trial, which was conducted at Englewood Hospital and Medical Center, NJ. Thirty patients were studied in this IRB-regulated trial. This was the first human subject trial done in the world.

“Initial results are very encouraging,” Dr. Elias said. “The success rates are equal to the early results of radiofrequency or laser treatment of great saphenous vein disease. The main advantage is that the technique does not require tumescence anesthesia infusion, thus saving significant time and decreasing patient discomfort. In addition, no generator is required and capital and maintenance cost is reduced. This in-office procedure takes about 15 minutes to perform and patients walk out of the office resuming normal activity that day.”

The ClariVeinTM catheter is a product of Vascular Insights LLC (vascularinsights.com) 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. The company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ClariVeinTM for infusion of physician-specified agents in the peripheral vasculature.

Dr. Elias spoke at the 9:00 am session in the Prince Pierre room of the Grimaldi Forum in Monaco, France and will speak again on September 25, 2009 at the Philadelphia at the Eastern Vein Society.

Director, Center for Vein Disease Mout 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 School of Medicine 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 and 2010 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.