Vascular Insights announced today that it has won approval for use of the CE Mark on its ClariVein® Occlusion Catheter, paving the way for marketing of the device in Europe.
The ClariVein® Occlusion Catheter is an infusion catheter system intended for the treatment of incompetent veins. Infusion is through an opening at the distal end of the catheter and fluid delivery is enhanced by the use of a rotating dispersion wire to mix and disperse the infused fluid in the blood stream and on the vessel wall.
The device was certified for conformance to European standards by Notified Body BSI (the British Standards Institution). The ClariVein® Occlusion Catheter device complies with the requirements of Council Directive 93/42/EEC, Annex II, Section 3.2.
Compared to radiofrequency or laser therapy, a key advantage of ClariVein® is that it does not require tumescence anesthesia, saving significant time and decreasing patient discomfort. In addition, a generator is not required, and therefore capital and maintenance cost is reduced. The in-office procedure is fast and essentially pain free. Early results suggest efficacy rates equivalent to those of radiofrequency and laser.
The ClariVein® Occlusion Catheter, available only in Europe, is a product of Vascular Insights LLC (http://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. Vascular Insights LLC is certified ISO 13485: 2003.
Vascular Insights has named European Medical Device Distribution of Cambridge, UK, as a distributor in United Kingdom, Netherlands, Germany, Italy, Spain, Portugal, Switzerland, Austria, Czech Republic, Poland, and Turkey. The Company's Authorized European Representative is MediMark Europe, Grenoble, France.
A photo of the device can be downloaded from http://vascularinsights.com/blue-tip-1176.jpg
In the United States, Vascular Insights has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ClariVein® infusion catheter, for infusion of physician-specified agents in the peripheral vasculature.
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