Salient Imaging is a U.S. corporation specializing in medical imaging software algorithms, specifically focusing on the development of patented technology for ultrasound imaging. Their product, Visualize:Vascular, employs pattern recognition to generate accurate 3D renderings of vascular structures and offers significant clinical value compared to traditional imaging methods such as Doppler and MRA. Clinical studies indicate that Visualize:Vascular provides more reliable results in assessing stenosis and plaque conditions, with high correlation rates to MRA results.

1. Document #:600-03-00021 Rev AA

2. Salient Imaging
pioneer in the development of medical imaging software algorithms
 Private U.S. Corporation
 Patented Technology in Imaging Algorithms
 U.S. FDA certified product: Visualize:Vascular™
 1st 3D rendering from 2D ultrasound focusing on the true lumen
Company

3. Salient Imaging’s technology is based on proven pattern recognition principles
Pattern Recognition is a well established and widely used method of identifying
and classifying complex data sets
 Mammography
 Lung
 Colon
 Liver
 Brain Tumor
Salient Imaging applies these proven practices to medical imaging to specifically
focus on ultrasound
Technology

4. Salient Imaging’s technology is based on proven pattern recognition principles
Pattern Recognition is a well established and widely used method of identifying
and classifying complex data sets
 Mammography
 Lung
 Colon
 Liver
 Brain Tumor
Salient Imaging applies these proven practices to medical imaging to specifically
focus on ultrasound
Technology

5. Visualize:Vascular
Current technology The crucial diagnostic The Salient Image
shows the outside information is inside of the residual lumen
of the carotid artery the carotid artery in the ICA
 Find the overriding pattern
 Identify the anomaly
 Create focused 3D rendering
 Automatically measure and calculate luminal reduction / Stenosis
 Provide clinicians with focus on the salient diagnostic detail

6. Technology
Works on a transverse cine clip of the artery

7. Technology
Finds the lumen on each frame

8. Visualize:Vascular Technology
Finds the lumen on each frame
Reconstructs 3D rendering of the lumen

9. Visualize:Vascular Technology

10. Clinical Value
Comparison of CDE to Visualize:Vascular to MRA
• 100 consecutive cases
• Any case where Visualize disagreed with Doppler or >70% on either also had MRA
Key Findings:
Correlation between CDE to Visualize 75%
Correlation between MRA and Visualize 99%
Gurell, et. al. ACR/SRU 2012
Key Findings:
Correlation between CDE to Visualize 75%
Correlation between MRA and Visualize 99%

11. The images to the left are from a study comparing the
results of 2D Ultrasound to 3D Visualize:Vascular over
the same section of the carotid artery
Top Image: Ultrasound color flow can mis-lead
 Measured Moderate Stenosis of 50 to 69%
 Measurement is made in color block at left which is beyond the
Stenosis (black)
 Ultrasound data indicates patient call back in 1 yr
Bottom Image: Visualize:Vascular is more accurate
 Measured Severe Stenosis (85%)
 Visualize data indicates immediate surgery
Visualize:Vascular is Correct
 Pathology confirmed that Visualize:Vascular is correct. Patient has
severe amount of plaque in vessel.
Clinical Significance – Shadowing

12. Ultrasound
Some plaque
The complete outline and
extent of the plaque
Visualize:Vascular
Magnetic Resonance Angiography (MRA) Break
Clinical Significance – Poor Fidelity
The images to the right are from a case study
comparing the results of 2D Ultrasound and
MRA technologies to Visualize:Vascular the
over the same section of artery
Top Image: Ultrasound
shows the outer arterial walls with limited detail of the
lumen pathway, no significant plaque
Middle Image: Visualize:Vascular
Significant vulnerable plaque
provides the most clinical detail about the region of
interest
Bottom Image: MRA
shows that there is an occlusion by the break, but does not
give specific detail
Pathology confirmed results from Visualize

13. Ultrasound
Velocities show 80-89%
Visualize:Vascular
▪No significant concern, 52%
MRA
No significant concern, no break
MRA confirmed results from Visualize
Clinical Significance – Tortuosity

14. Ultrasound
Velocities show 70-79%
Visualize:Vasclar
Over 80%
Clinical Significance –Turbulence

15. Ultrasound
Velocities show 70-79%
Visualize:Vascular
Over 80%
Clinical Significance –Turbulence

16. Ultrasound
Velocities show 70-79%
Visualize:Vascular
Over 80%
Clinical Significance –Turbulence

17. Ultrasound
Velocities show 50-69%
Visualize:Vascular
Significant concern, 92%
CTA
Significant concern, 90%
CTA confirmed results from Visualize
Clinical Significance – Artifact?

18. The procedure should be performed on patients who demonstrate medical
necessity observed during the primary exam:
Noted Presence of Plaque
Noted Presence of Tortuosity
Noted Presence of Artifacts: Shadowing, Speckling, Fidelity Concerns
Noted Presence of Turbulent Flow Conditions
Follow-up to Surgery or Interventional Procedure
Medical Necessity

19. Document #:600-02-00003 Rev AA