ClariVein®: New Method for Vein Ablation Introduced in Europe

MADISON, Connecticut, July 14, 2010 — PRNewswire

The ClariVein® Occlusion Catheter was introduced at four medical facilities in Europe during the week of June 28, 2010.

The device is intended for endovascular occlusion of incompetent veins in patients with superficial venous reflux. ClariVein is a non-thermal approach that uses a mechanical rotating dispersion wire to mix and disperse a sclerosant on the vessel wall to cause ablation of a vein - for example, the great saphenous vein.

Reporting successful use of ClariVein in Germany was Thomas Proebstle MD PhD, Director of the Privatklinik Proebstle in Mannheim, and in the Netherlands, JPPM de Vries MD PhD and RHW. van de Morte MD at St. Antonius Hospital in Nieuwegein, MMPJ Reijnen MD PhD at Rijnstate Hospital in Arnhem, and Cees H.A. Wittens, MD PhD at Maastricht University Medical Centre in Maastricht.

Steve Elias MD FACS FACPh, Associate Professor of Surgery at Mount Sinai Hospital in New York and Director of the Centers for Vein Disease at Mount Sinai and at Englewood Hospital and Medical Center in New Jersey, attended the procedures to provide training and guidance. Dr. Elias conducted the first trials of the device in humans in the United States.

Compared to radiofrequency or laser therapy, a key advantage of ClariVein is that it does not require tumescence anesthesia, and can be used to treat near nerve bundles without concern for nerve damage. In addition, the device is fully disposable and a generator is not required. Capital and associated maintenance and operational cost are eliminated. The in-office procedure is fast and essentially pain free. Early results suggest efficacy rates equivalent to those of radiofrequency and laser.

At present available only in Europe, the ClariVein Occlusion Catheter carries the CE Mark. The device is a product of Vascular Insights LLC (http://vascularinsights.com [1]) of Madison, Connecticut. Vascular Insights LLC is certified ISO 13485: 2003 and was recently awarded a license to sell the ClariVein device in Canada.

Vascular Insights has named European Medical Device Distribution of Cambridge, UK, as a distributor in Europe. The Company's Authorized European Representative is MediMark Europe, Grenoble, France.

In the United States, Vascular Insights has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ClariVein(R) infusion catheter for infusion of physician-specified agents in the peripheral vasculature.