Vascular Insights' ClariVein Occlusion Catheter has won approval for use of the CE mark, paving the way for marketing of the device in Europe. The ClariVein Occlusion Catheter is an infusion catheter system intended for the treatment of varicose veins.
Vascular Insights said that the 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.
According to Vascular Insights, when 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. Early results suggest efficacy rates equivalent to those of radiofrequency and laser.
Vascular Insights is a designer, developer, manufacturer, and marketer of medical devices for the minimally invasive treatment of peripheral vascular disease.