| With technology licensed from Yale
University and our own IP, we are developing and will market
products based on mechanically enhanced drug delivery for
the minimally invasive treatment of peripheral vascular
disease.
ClariVein™ is a percutaneous, 2 2/3 Fr (0.035")
infusion catheter that contains a rotating wire driven by a
motor activated from a DC battery-powered handle. The system
provides even, controlled irrigation of a treatment site for
a physician-specified procedure with a physician-specified
therapeutic fluid.
Infusion is through an opening at the distal end of the
catheter and fluid delivery is enhanced by the use of a
rotating dispersion wire to mix and disperse the infused
fluid in the blood stream and on the vessel wall. During a
thrombectomy procedure, the wire may be used to macerate a
clot with minimum damage to the vessel wall.
The device is indicated for localized delivery of
therapeutic agents to the peripheral vasculature. It is
simple to operate and is single use and disposable. No
additional guidewire is need for placement and exchanges are
eliminated. It requires no capital expenditure by the
physician, clinic, or hospital.
Vascular Insights LLC has received 510(k) clearance from
the U.S. Food and Drug Administration (FDA) to market its
ClariVein™ infusion catheter for infusion of
physician-specified agents in the peripheral vasculature.
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