ClariVein(R): New Method for Vein Ablation Introduced in EuropeBy Vascular Insights Llc, PRNE
Tuesday, July 13, 2010
MADISON, Connecticut, July 14, 2010 - The ClariVein(R) 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(R) 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(R) in Germany was Thomas Proebstle
MD PhD, Director of the Privatklinik Proebstle in Mannheim, and in the
Netherlands, J.P.P.M. de Vries MD PhD and R.H.W. van de Morte MD at St.
Antonius Hospital in Nieuwegein, M.M.P.J 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(R) 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(R) Occlusion Catheter
carries the CE Mark. The device is a product of Vascular Insights LLC
(vascularinsights.com) of Madison, CT, USA. Vascular Insights LLC is
certified ISO 13485: 2003 and was recently awarded a license to sell the
ClariVein(R) 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
Bill Kelly HarveyMalis Communications LLC email@example.com +1-203-375-2696
Bill Kelly, HarveyMalis Communications LLC, bill at harveymalis.com , +1-203-375-2696
Tags: Connecticut, France, Germany, July 14, Madison, United Kingdom, Vascular Insights Llc