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Print Edition StoriesWednesday, May 7, 2008
Vascular Insights get FDA OK to sell infusion catheter
By Mass High Tech
Medical device company Vascular Insights LLC has won approval from the U.S. Food and Drug Administration to market its ClariVein infusion catheter.
The Madison, Conn.-based company received 510(k) clearance from the FDA for 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.
The ClariVein catheter, which contains a rotating wire driven by a motor to enhance fluid dispersion in the treatment area, is intended for minimally invasive treatment of peripheral vascular disease, according to Vascular Insights officials.
Vascular Insights was co-founded by John P. Marano and Michael Tal, based on Tal's studies into interventional procedures. Tal is chief medical advisor to the company and associate professor of radiology at Yale University School of Medicine.
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