March 29, 2013 — Fujifilm SonoSite Inc. announced the launch of AxoTrack Needle Guidance Technology on select SonoSite Ultrasound Systems. This newly developed product, named by Popular Science Magazine as one of 2012’s best new innovations, is now available for use with SonoSite M-Turbo Ultrasound Systems.
The launch comes with the news that SonoSite has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell specialized ultrasound transducers equipped with AxoTrack Technology engineered by Soma Access Systems LLC.
AxoTrack combines ultrasound with advanced magnetics to provide users with real-time visual updates of needle location as it travels through tissue to the intended target. The easy-to-use, “point-and-shoot” design can save time and may significantly improve procedure outcomes, particularly for vascular access. Pre-existing patient health conditions, like low blood pressure, can increase the risk of complications during these procedures. The ability to simply line up the target line with the vessel and then track the “virtual needle” into the vessel can improve patient safety and the confidence of ultrasound users performing guided procedures.
The AxoTrack System — designed for rapid ease of use — is composed of a specially designed ultrasound transducer from SonoSite and a single-use sterile procedure kit from Soma Access Systems LLC.
“AxoTrack Needle Guidance Technology for SonoSite Systems brings a timely solution to health systems. By reducing vascular access time and enhancing patient safety, AxoTrack can ultimately reduce procedural risks and costs at a time when all of these points really matter to health systems,” said Kevin M. Goodwin, SonoSite’s president and CEO. “It is well recognized that ultrasound visualization improves the accuracy and safety of deep needle-based procedures. AxoTrack takes this to a new level by reducing the spatial coordination required when a needle tip is typically not seen. Now physicians can observe the ‘virtual needle’s’ movement on the screen so they can be more accurate and avoid observed critical structures such as the carotid artery or the lung pleura.
“We are confident this ‘point-and-shoot’ technology will significantly improve outcomes and also make guided procedures far more approachable for new users by addressing the coordination challenges sometimes faced with ultrasound needle guidance.”
An in vitro study using AxoTrack resulted in vascular access procedures that were successful on the first pass and first stick 99.3 percent of the time versus just 37.1 percent of the time when compared to the standard freehand method for ultrasound-guided central venous access.
“For the first time, clinicians have clear sight of needle location as it moves inside the human body,” said Dexter Hagy, president and CEO of Soma Access Systems LLC. “This means fewer passes for difficult-to-reach targets, greater success rates, and increased physician confidence, setting a new standard of care throughout the medical industry.”
After nearly a decade of research and development, Soma Access Systems has refined AxoTrack into a simple and highly effective tool for a variety of ultrasound-guided procedures.
Concludes Goodwin, “The SonoSite collaboration with Soma to bring AxoTrack to market adds a new degree of safety, accuracy, and cost-effectiveness for health systems. Physicians that have seen the technology are amazed, and we have a large SonoSite customer base that has been waiting for it.”
AxoTrack Technology is available in the United States through SonoSite.
1 Ferre, R.M., et al. The Use of a Novel Device Improves Real?Time Ultrasound Guided IV Access. Supplement to Annals of Emergency Medicine, Sept. 2010; 56:3:S74.