Vascular Insights Receives FDA Clearance For Infusion Catheter

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 May 2008 - 0:00 PDT

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Vascular Insights LLC announced 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.

Vascular Insights LLC
http://vascularinsights.com