Technology

FibroScan® is the first and only point of care device specifically developed and FDA-Cleared as an aid to the clinical management of patients with liver disease. It has been extensively studied across over 1,200 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® system 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® 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 clinical management of adult patients with liver disease. Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.

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 1200 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.

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. Currently available on the FibroScan® 502 Touch only.
  • 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.