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FDA Clears Catheter Guidance System

SonoSite Inc. of Bothell, Washington, a maker of ultrasound medical devices, says it received U.S. Food and Drug Administration clearance for its LumenVu Catheter Guidance System, designed to direct the placement of peripherally inserted central catheters (PICC).

The company says LumenVu combines near-infrared technology with a fiber optic stylet, which replaces a traditional guide wire, to allow visualization and real-time tracking of a catheter tip as it advances through a vein. While PICCs have become a common procedure, they involve some risks and complications. According to the company, the LumenVu system, helps improve the odds of a successful first insertion, thus reducing the need for reinsertion, which reduces risks of infection and other complications.

Sonosite says LumenVu provides clinicians with the ability to visualize the catheter tip as it travels through the vessel, and track the progression of a catheter with greater confidence and make navigational adjustments, if necessary.

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