SonoSite Receives FDA Clearance for LumenVu Catheter Guidance System
August 26 2010 - 4:39PM
Business Wire
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 20081, 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
attempt2. 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.
For more information about the LumenVu System, visit
www.sonosite.com/products/lumenvu/.
About SonoSite
SonoSite, Inc. (www.sonosite.com) is the innovator and world
leader in bedside and point-of-care ultrasound and an industry
leader in ultra high-frequency micro-ultrasound technology and
impedance cardiography equipment. Headquartered near Seattle, the
company is represented by ten subsidiaries and a global
distribution network in over 100 countries. SonoSite’s small,
lightweight systems are expanding the use of ultrasound across the
clinical spectrum by cost-effectively bringing high-performance
ultrasound to the point of patient care.
1 Moureau N Vascular Safety: It’s all about PICCs Nursing
Management 2006: Volume 37 Number 5 22- 27
2 Trerotola SO, Thompson S, Chittams J, Vierregger KS Analysis
of Tip Malposition and Correction in Peripherally Inserted Central
Catheters Placed at Bedside by a Dedicated Nursing Team J Vasc
Interv Radiol 2007; 18: 513 – 518
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