Vascular Insights Receives FDA Clearance for Infusion Catheter


July 9, 2008

Vascular Insights received 510(k) clearance from the FDA to market its ClariVein infusion catheter for infusion of physician-specified agents in the peripheral vasculature.

ClariVein is a percutaneous, 2 2/3 Fr (0.035-inch) catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area.

Other products by the company include ClariVein-VA, which is engineered to allow varicose vein disease correction with a minimally invasive, small caliber (2 2/3 French), soft, flexible infusion catheter. ClariVein-IC, a general infusion catheter that can be used, for example, to treat Deep Vein Thrombosis (DVT).

Exchanges are eliminated, and the system provides even, controlled irrigation, designed to facilitate well-dispersed drug coverage of the target tissue, reducing the washing away of the therapeutic agent into the bloodstream. The FDA has not yet cleared ClariVein-VA and ClariVein-IC for marketing in the U.S.