Accurate Guidance. Confident Outcomes.

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CLINICAL VERSATILITY

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Sterile disposable needle

Reusable needle handle

Sheath

Sheath hub

Stylet

eTRAX allows real-time visualization of needle trajectory and tip in relation to surrounding anatomy.

CIVCO’s eTRAX™ is a breakthrough technology that enables precise needle tip tracking to expand the capabilities of ultrasound interventions.

eTRAX allows users to clearly visualize the location and orientation of the needle as it advances towards the anatomical target. Featuring a sensor embedded into the needle tip, eTRAX offers a 3D anatomical road map to help physicians navigate through delicate tissues or diffcult-to-access targets with greater accuracy and efficiency.

• Abdomen5,6 • Pancreas6

• Kidney3 • Prostate3

• Liver1,2, 3 • Thyroid8

In addition to biopsies, other therapeutic interventions can be considered, such as cryoablation and radiofrequency.1 A growing evidence base for electronic tracking technology covers a range of clinical applications:

Like never before, eTRAX provides safe and easy access to small or difficult-to-access targets and helps improve patient safety and outcomes while minimizing the need for radiation or invasive surgery.

eTRAX Needle Tip Tracking providesaccurate real-time navigation for a range of clinical interventions.

Clinical experience with eTRAX supports: • Accurate navigation • Access to difficult anatomy • Confident outcomes

Discover how leading physicians are using eTRAX today.

Recent clinical research supports the benefits of eTRAX. Our study shows the advantage of this new needle guidance modality during needle intervention with a high technical success, high accuracy, short procedure time, low complications rate, and easy operability.1

Antoine Hakime, MD, et al. Gustave Roussy Institute Paris, France

ACCURATE NAVIGATION ACCESS TO DIFFICULT ANATOMY

Visibility of needle tip throughout the procedure.

Electromagnetic needle tracking of the needle tip enables continuous visualization of the needle tip during the entire procedure, because the needle tip is electronically marked on screen. For conventional image guided biopsy with mechanical needle guidance the registration of the echoes from the needle tip may be difficult especially in large depths and in areas with overlying air.4

Access targets not visible under conventional ultrasound.

We successfully evaluated image fusion using CT and US (ultrasound) and electromagnetic needle tracking for US-guided percutaneous drainage of air-containing cavities with poor US-overview in three patients with severe, complicated postoperative courses. The challenge in all three cases was that the cavities contained air, thus limiting the overview of the cavity and the needle guidance by conventional US.5

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Clinical studies report a high level of accuracy and safety using eTRAX Needle Tip Tracking. Easy, fast and safe needle placement.

The consequential positive impact on needle tip localization and needle path prediction have led to increased accuracy of ultrasound (US)-guided electromagnetically tracked biopsies. Such high level of accuracy have permitted easy, fast, and safe needle placement in targeted liver nodules, with a low complication rate, regardless of lesion conspicuity and location or operator experience.2

Safe interventions.

Real-time image fusion with ultrasound and electromagnetic needle tracking allow highly accurate and safe intervention in areas that are normally not visualized or are difficult to visualize sonographically, for instance, areas covered by air or hidden behind bone or lesions only seen on CT, MRI, or PET.3

When fusing ultrasound with other modalities such as CT, eTRAX helps reach small, difficult targets with precision.

Evidence demonstrates eTRAX provides access to targets normally difficult to visualize under conventional ultrasound.

With eTRAX, the needle tip is clearly marked with ‘N’ on the screen and tracked as it advances toward the target anatomy.

1. Hakime A, Deschamps F, De Carvalho E G M, Barah A, Auperin A, and De Baere T. “Electromagnetic-Tracked Biopsy under Ultrasound Guidance: Preliminary Results.” Cardiovascular and Interventional Radiololgy. 35.4 (2012): 898-905. 2. Hakime A, Barah A, Deschamps F, Farouil G, Joskin J, Tselikas L, Auperin A, and De Baere T. “Prospective Comparison of Free-hand and Electromagnetic Needle Tracking for US-guided Percutaneous Liver Biopsy.” Journal of Vascular and Interventional Radiology (JVIR). 24.11 (2013): 1682-1689.

3. Ewertsen C, Saftoiu A, Gruionu L G, Karstrup S, and Nielsen M B. “Real-Time Image Fusion Involving Diagnostic Ultrasound.” American Journal of Roentgenology. 200.3 (2013): 249-255.

4. Ewertsen C, Dencker D, and Karstrup S. “Core Needle Biopsy from a Small Retroperitoneal Lymphoma Guided by Image-Fusion and Electromagnetic Needle Tracking.” Ultraschall in der Medizin - European Journal of Ultrasound. 33.1 (2012): 1-3.

5. Dencker D, Ewertsen C, and Karstrup S. “Drainage of Air-Containing Cavities Guided by Image Fusion involving Ultrasound and Electromagnetic Needle Tracking.” Ultraschall in der Medizin - European Journal of Ultrasound. 33. (2012): 489-492.

6. Dencker D, Ewertsen C, and Karstrup S. “Drainage of Poorly Visualized Areas Guided by Image Fusion Involving Ultrasound and Electromagnetic Needle Tracking. Poster session presented at: Euroson; 2012 April 22-24, Madrid, Spain.

7. Jung E M, Friedrich C, Hoffstetter P, Dendl L M, Klebl F, Agha A, Wiggermann P, Stroszcynski C. and Schreyer A G. “Volume Navigation with Contrast Enhanced Ultrasound and Image Fusion for Percutaneous Interventions: First Results.” PLoS ONE. 7.3 (2012): n. page.

8. Turtulici G, Corazza A, Sartoris R, Arcidiacono A, Nosenzo F, Perugin Bernardi S, Silvestri E. “Virtually-tracked US-guided Radiofrequency Ablation (RFA) of Benign Thyroid Nodules: Preliminary Results.” Poster session presented at: ESHNR 2013 October 3-5, Izmir, Turkey.

Reduced procedure times.

EMT significantly reduces needle placement time and the number of needle pullbacks in comparison with conventional methods used for liver biopsy and also seems to make the procedure easier from a technical standpoint.2

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CONFIDENT OUTCOMES REFERENCES

Procedure and Outcome Variable Comparisons between EMT and Free-hand Groups2

VariableEMT

(n = 30)Free-hand

(n = 30)

P Value

Needle placement time (seconds) .0001

Mean ± SD 45.8 ± 48.1 143.2 ± 122.1

Median (range) 30 (5-240) 116 (10-420)

No. of pullbacks for redirection < .0001

Mean ± SD 0.50 ± 0.86 1.83 ± 1.26

Median (range) 0 (0-3) 2 (0-5)

SD = standard deviation

High success rates.

Percutaneous biopsies and drainages, even of small lesions involving complex access pathways, can be accomplished with a high success rate by using 3D real-time image fusion together with real-time needle tracking.7

Reported patient and procedure outcomes demonstrate the clinical ultility of eTRAX for a range of procedures.

Avoid invasive surgical procedures.

The patients were successfully treated by percutaneous US-guided drainage using image fusion (US/CT) and electromagnetic needle tracking. All patients avoided surgery.6

COPYRIGHT© 2013. CIVCO AND ETRAX ARE TRADEMARKS OF CIVCO MEDICAL SOLUTIONS. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2013R-2700

Accurate Guidance. Confident Outcomes.

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