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August 25, 2010
FDA Clears SonoSite's LumenVu Catheter Guidance System
August 26, 2010—SonoSite, Inc. (Bothell, WA) announced that it has received clearance from the US Food and Drug Administration for the LumenVu catheter guidance system. The LumenVu system is designed to aid in the placement of peripherally inserted central catheters. The device combines near-infrared technology with a fiber-optic stylet, which replaces a traditional guidewire, to allow visualization and real-time tracking of a catheter tip as it advances through a vein.
According to the company, the LumenVu system has the potential to mitigate the risks of unsuccessful first insertions by providing clinicians with the ability to visualize the catheter tip travelling through the vessel, to track the progression of a catheter with greater confidence, and to quickly make navigational adjustments, if necessary. The LumenVu system is compatible with standard catheter products and is designed to allow integration into clinicians' current peripherally inserted central catheter line process. Additionally, the LumenVu system does not rely on a magnetic field and will not interfere with medical equipment or with devices in the patient's body, such as a pacemaker, SonoSite stated.
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