MADISON, Conn., May 6 /PRNewswire/ -- Vascular Insights LLC announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ClariVein(TM) infusion catheter for infusion of physician-specified agents in the peripheral vasculature.
ClariVein(TM) is a percutaneous, 2 2/3 Fr (0.035") catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area.
"We are delighted with this development," said John P. Marano, co-founder, president, and chief executive office of Vascular Insights. "The FDA decision clears the way for the commercialization of ClariVein(TM) and promises to dramatically shorten our time-to-market."
Vascular Insights LLC (http://vascularinsights.com) of Madison, Conn.,
engages in the design, development, manufacture, and marketing of medical
devices for the minimally invasive treatment of peripheral vascular
disease. The company was co-founded by John P. Marano and Dr. Michael Tal,
based on Dr. Tal's insights into interventional procedures. Dr. Tal is
chief medical advisor to the company and associate professor of radiology
at Yale University School of Medicine.
HarveyMalis Communications LLC
|SOURCE Vascular Insights LLC|
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