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 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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