Technology

 

FibroScan® is the first and only point of care device specifically developed and FDA-Cleared as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver. It has been extensively studied across over 1,780 peer reviewed publications and is the reference for many treatment guidelines.


 

FibroScan® Approved Indications

The intended use/indications for use for the FibroScan® are as follows:

The FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter) in internal structures of the body.
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).
The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.
Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.

Additionally, the FibroScan® technology complies with all applicable rules governing the level of energy applied and absorbed to the human body, including mechanical indexes and heat dissipation.

 


 

Dual Function Capability

Only FibroScan® can provide dual function liver testing: Echosens patented VCTE and CAP assessments. These are simultaneously acquired during a simple, time efficient and accurate examination. Together, VCTE and CAP can provide important information to inform the assessment of your patient’s liver health.

 

 

What is VCTE?

FibroScan® assesses liver stiffness using a patented technique called Vibration-Controlled Transient Elastography (VCTE). VCTE is recognized worldwide as the original and most extensively studied technology for liver stiffness assessment. VCTE has been included in over 1780 peer review publications and is across most clinical practice guidelines.

In the VCTE assessment, a controlled 50 Hz frequency shear wave is mechanically induced. The propagation speed of the shear wave is measured with pulse echo ultrasound. Liver stiffness is calculated using the Young’s Modulus formula. Scientific validation establishes that high shear wave speed correlates to high liver stiffness. During the VCTE measurement, ultrasound attenuation rate of the liver is concurrently measured. Liver ultrasound attenuation rate, known as CAP, can provide additional information to aid in the management of liver disease.

Read our White paper about VCTE
Download the White paper about VCTE

 

 

What is CAP?

To complement the VCTE assessment, FibroScan® measures the ultrasound attenuation rate in the liver using a patented technique called Controlled Attenuation parameter (CAP). In the CAP technique, ultrasound attenuation rate is measured simultaneously in the same 3cm3 region as the assessment of liver stiffness. This approach minimizes the operator’s effort while assuring the assessment is performed in the center of the liver parenchyma.

Watch the 3 stages of the FibroScan® Examination Video

 


 

 

Different FibroScan® Probes for Different Patients

To optimize measurement accuracy, FibroScan® offers a range of probe models which match the measurement area of most patient morphology. By adjusting the measurement area relative to the distance of the liver below the skin’s surface, a consistent 3cm3 explored volume can be maintained.

  • S+ Probe, Pediatric: Designed for smaller stature patients with a thoracic perimeter less than 75cm.
  • M+ Probe, Medium: Designed for adults in which the distance from the skin to the liver capsule is 25mm or less.
  • XL+ Probe, Extra Large: Designed for heavier weight adults in which the distance from the skin to the liver capsule over 25mm.

The probes are ergonomically designed for operator comfort and improved test accuracy, irrespective of variations in patient morphology.

Probe Selection Criteria

Ensure that the probe is calibrated & the correct probe is used corresponding to the patient’s body type:

  • To choose between M or XL probe on adults, follow the automatic probe selection tool displayed in real time, based on the Skin to Liver Capsule Distance (SCD), and not on patient’s BMI.
  • For children, probe selection criteria are based on thoracic perimeter (TP).
  • Probe selection algorithm is given in the below illustration.

 

Examination Reliability Criteria

  • At least 10 measurements at the same spot shall be performed with one single probe.
  • Liver stiffness IQR/Median ratio (%) shall remain ≤30% when final median stiffness result exceeds 7.1 kPa2
  • Operator shall be duly trained and certified by Echosens or its local representative. The present document is not intended to provide user training.

 

 

References

  1. Mederacke I, Wursthorn K, Kirschner J, Rifai K, Manns MP, Wedemeyer H, Bahr MJ. Food intake increases liver stiffness in patients with chronic or resolved hepatitis C virus infection. Liver International 2009;29:1500-1506.
  2. Arena U, Lupsor Platon M, Stasi C, Moscarella S, Assarat A, Bedogni G, Piazzolla V, et al. Liver stiffness is influenced by a standardized meal in patients with chronic hepatitis C virus at different stages of fibrotic evolution. Hepatology 2013;58:65-72.