Vascular Insights infusion catheter nets FDA clearance

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

ClariVein is a percutaneous, Fr (0.035-inch) catheter, containing a rotating wire driven by a motor that enhances fluid dispersion in the treatment area, according to the Madison, Conn.-based company.

The FDA has approved the catheter to be used in infusion of liquids as a treatment for peripheral vascular disease, which affects the blood vessels carrying blood supply to the legs, arms or organs other than the heart or brain, Vascular Insights said.

“The FDA decision clears the way for the commercialization of ClariVein and promises to dramatically shorten our time-to-market,” said John P. Marano, co-founder, president, and CEO of Vascular Insights.