eTRAX™: CIVCO’s Breakthrough Needle Guidance System

eTRAX: CIVCO’s Breakthrough Needle Guidance System

CIVCO Medical Solutions has introduced eTRAX, a breakthrough needle guidance system, expanding real-time image-guided navigation into a new dimension. Featuring an electromagnetic sensor embedded into the needle tip, eTRAX is an image-guidance tool kit which supports image fusion for ultrasound and enables real-time 3D instrument guidance in a variety of clinical settings. eTRAX acts as a real-time, 3D anatomical roadmap for the body, aiding in minimally invasive procedures.

Paired with a sterile sheath, eTRAX’s electromagnetic (EM) tracking needle guidance enables accurate placement of a broad spectrum of standard instruments using co-axial technique. Given the ability to fuse other imaging modalities with ultrasound, eTRAX provides physicians with a greater range of choices for targeting and supremely accurate tool for tracking of the tip of a needle under real-time, image-guided navigation.  “The eTRAX tool kit is unique in both its design and clinical versatility,” said Dr. Bill Whitmore, MD, Chief Medical Officer at CIVCO. “The system is also designed to allow indefinite re-use of the relatively expensive active EM tracking sensors.”

EM tracking with eTRAX provides significant clinical advantages, including increased clinical confidence in targeting difficult to access lesions. “Ultrasound alone cannot always provide clinical confidence, often due to multiple tissue interfaces, bone or air blockages,” explained Jack Scully, Vice President of Ascension Technology Corporation. Ascension developed and manufactures the EM tracking sensors used in eTRAX.  “Importantly, EM tracking allows both in and out-of-plane navigation to optimize the needle’s trajectory to a lesion,” continued Scully. “With 3D guidance, the physician can independently position both the biopsy needle and an ultrasound transducer for the safest and fastest target access.”

With eTRAX, ultrasound brackets enable attachment of a sensor for real-time image fusion and also support an in-plane mechanical guide for ease of instrument orientation during ultrasound assisted targeting. Coupled with an OEM ultrasound system, eTRAX can improve the safety, speed and accuracy of instrument placement and save costs by reducing both procedure time and complications.

eTRAX in Action

Dr. Thierry de Baere, head of Interventional Radiology at the Institut Gustave Roussy in Villejuif, France, worked with CIVCO to validate the eTRAX system. “The system components are easy to work with, fast to setup before a biopsy, and very intuitive,” said de Baere.  CIVCO’s guidance system may be used with devices for numerous applications; de Baere and his group initially used the system for tissue biopsy, but plan to utilize eTRAX during ablation procedures as well.  “We biopsied six patients using the eTRAX guidance system, and all patients were successfully biopsied with rapid placement of the needle within the target,” said de Baere. “eTRAX allows you to follow the progression of your needle tip more easily, due to the excellent accuracy of the system.”

de Baere also took advantage of eTRAX’s flexibility during the validation testing. “It allows different access routes for the needle and the imaging, which is really useful when an intercostal access is chosen for a liver biopsy,” he said. “We could appreciate that in two of our six biopsies. It is much more flexible than any guiding kit linked to the probe.”

Scully emphasizes the safety aspect of EM tracking for interventional procedures, such as those performed by de Baere. “Faster, more accurate and safer procedures reduce costs and patient trauma,” he said. “For deep-seated lesions, the data is showing EM tracking facilitates 100% success with a single needle stick. The technology is especially helpful in enabling biopsy procedures to be performed successfully by less experienced physicians while significantly shortening an otherwise steep learning curve.” de Baere, a highly experienced physician, also appreciates eTRAX’s short learning curve, as well as the easy to understand display provided by OEM software.

As eTRAX continues to develop and is used by more clinicians, de Baere sees continued benefits to both patient and clinician. “In the future, it will probably contribute to shortening the overall biopsy time, namely the duration of the needle placement itself,” he said. “Consequently, the procedure will be better tolerated by the patient. In a few cases, it might reduce the number of punctures.”

Whitmore agrees and underscores the increase in clinical confidence gained through eTRAX usage. “Any physician using images for guiding a medical procedure wishes to ‘see’ and to feel comfortable knowing exactly where they are going, in real-time, as accurately as possible,” he said. “Electromagnetic instrument tracking and multi-modality image fusion with accurate registration is the current state of the art for satisfying this need.”

Evolution and Future of Tracking Technology

The EM tracking technology at the core of eTRAX has a significant history, developing from a military technology to a commercially viable medical accessory over the course of the last 30 years.  Vermont-based Ascension Technology Corporation supplies eTRAX’s EM tracking sensors. “Sensor-driven ultrasound is the ultimate hand-eye coordinator,” said Scully. “It lets the physician see the needle tip, the internal target, and the anatomy in real-time – without radiating the patient or the clinician.”

eTRAX enhances the value of image fusion, which in itself has been a major technological advancement in the image-guidance industry recently. GE Healthcare’s LOGIQ E9^©, Ultrasonix’s SonixTOUCH^™ and Esaote’s Virtual Navigator^™ all offer image fusion and assisted navigation for interventional and ultrasound procedures.  Philips Healthcare recently acquired Toronto-based Traxtal, Inc. Traxtal has been a pioneer in EM tracking and guidance with their PercuNav computer assisted image-guidance system. PercuNav, like eTRAX, utilizes both multi-modality image fusion and EM tracking needle guidance.

eTRAX and PercuNav are today’s cutting-edge technology – developed to better patient care and enhance clinicians’ capabilities. Whitmore and Scully see EM tracking becoming the stand of care for image-guided procedures. As that happens, the technology involved will continue to develop rapidly. Whitmore sees software, hardware and robotics advancing congruently. “Hardware will advance in parallel to the point where precise 4D instrument navigation using active tracking will be paired with robotics,” said Whitmore. “This will enable a qualified clinician to precisely and safely target a lesion with a single pass of the instrument anywhere in the body from a remote console using something similar to a joystick in a video game. This will be dramatically safer for both the patient and the physician.”

Scully believes eventually there will be a progressive reduction in the cost of EM tracking sensors. “The next frontier will be truly disposable, low-cost sensors,” said Scully. “It will happen once sensor-driven ultrasound becomes standard practice. We also will see steady advances in signal processing and metal immunity that will widen applications and acceptability in numerous new image-guidance procedures. Long-term, first embedded, and then wireless sensors will make tracking less obtrusive and permit tighter integration into medical instruments become standard issue.”

The evolution of EM tracking for image-guided medical interventions will continue to benefit both patient and clinician. “Electromagnetic tracking alone and possibly in combination with other tracking methods will increasingly be applied for image-guided medical interventions,” said Whitmore. “As imaging technology advances and image management and workflow software improves, more accurate diagnoses, treatment planning and faster, safer targeting will be further supported by increasingly accurate and continuously updated image fusion.”

eTRAX, and its counterparts, are a significant step in this direction. For more information on eTRAX, please visit www.CIVCO-etrax.com.