FDA clears SonoSite's LumenVu Catheter Guidance System

SonoSite, Inc. (Nasdaq:SONO), the world leader and specialist in bedside and point-of-care ultrasound, announced today that it received FDA clearance for its innovative LumenVu® Catheter Guidance System. Designed to aid in the placement of peripherally inserted central catheters (PICC), the proprietary LumenVu System combines near-infrared technology with a revolutionary 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.

"Receiving FDA clearance is an important milestone in the strategic development and global commercialization of the LumenVu System and it reinforces our dedication to providing patients with improved safety and health," said Kevin M. Goodwin, SonoSite's President and CEO. "We envision this technology ultimately advancing beyond PICC line placements and potentially into a broader range of clinical applications. This clearance also represents a significant step towards the development of a fully integrated line placement imaging solution, which will include ultrasound visualization."

An estimated 2.5 million PICC line placements were performed in the United States in 2008, making it one of the most rapidly growing applications performed in the hospital setting. Although a common procedure, PICC placements do pose risks and potential complications. A recent University of Pennsylvania Medical Center study found that only 70% of PICC lines are successful on the first attempt. Catheters are often incorrectly placed and need to be re-inserted or repositioned by the clinician, which results not only in more time and greater expense, but also increases the risk of infections.

The LumenVu System has the potential to mitigate these risks by providing clinicians with the ability to visualize the catheter tip as it travels through the vessel. Healthcare professionals in hospitals or long-term care facilities will be able to track the progression of a catheter with greater confidence and quickly make navigational adjustments, if necessary.

This proprietary solution potentially offers a number of advantages in the PICC marketplace. The LumenVu System is compatible with standard catheter suppliers and is designed to allow clinicians seamless integration of the product into their current PICC 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.

Several hospitals in Europe are currently evaluating the LumenVu Catheter Guidance System in their clinical practices.