FibroTouch Device Allows Efficient Early Diagnosis of Liver Diseases

According to the latest World Health Organization data, approximately 325 million people on the Earth live with chronic infection caused by the hepatitis B virus (HBV) or the hepatitis C virus (HCV).

Roughly estimated, 5% of the world’s population suffers from various liver diseases, and only 5% of them are aware of it.

These figures mean that if you have 200 friends on Facebook, 10 of them have various liver diseases and most probably do not know about it!

 

 

The liver is the largest gland in the human body, which is divided into 4 lobes or 8 segments and performs more than 500 functions.

 

The main liver functions are recollected below:

 

  • Detoxification;
  • Digestion;
  • Protein synthesis;
  • Hormones metabolization regulation;
  • Deposition.

 

 

Viral hepatitides are among the main causes of liver diseases. People residing in hyper-endemic regions are particularly at risk because of the peculiar climate, lifestyle, and nutrition.

 

Other common liver diseases are as follows:

 

  • Fatty hepatosis;
  • Alcoholic hepatosis – the condition develops as a result of alcohol abuse;
  • Non-alcoholic fatty liver disease.

 

Both in the first and in the second case, the organ is damaged because of lipid inclusions or adipose tissue accumulation in hepatocytes.

According to figures from the Federal State Statistics Service (Rosstat), more than 50,000 people die from various liver diseases every year in the Russian Federation!

 

Why is the statistic data so bad?

 

  • Insufficient attention to this problem on the part of government medical and preventive treatment facilities and especially private health centers;
  • No mandatory medical examination in the Russian health care system;
  • Low efficiency of the available diagnostic methods;
  • Problems connected with early diagnosis;
  • No nerve endings in the liver;
  • Asymptomatic disease progression.

 

 

Liver diseases pose a serious public health threat on an international scale, comparable to other infectious diseases such as HIV infection, tuberculosis, and malaria.

 

 What to do?

 

  • Try to translate the problem urgency to people;
  • Revise available methods for early liver disease diagnosis;
  • Introduce the hepatological service into the Russian Federation Health System;
  • Create a network of public and private healthcare centers fitted with modern diagnostic equipment to make early liver diagnostics accessible in all areas of the Russian Federation.

 

Liver disease diagnosis methods

 

As of this day, there are invasive and non-invasive methods used to diagnose pathological processes in the liver.

The invasive methods include liver biopsy which is considered to be the gold standard in diagnosing chronic diffuse diseases. However, due to high risks of complications and elaborate surgical intervention procedures, though minimal, a biopsy procedure cannot be used to diagnose a wide audience of patients or for preventive medical examination.

 

The non-invasive liver disease diagnosis methods include:

 

  • Immunological tests;
  • Ultrasound examination (elastography method);
  • CT scan;
  • MRI.

 

Immunological and biochemical blood tests exhibit a sufficiently poor accuracy, type specificity, and high cost – factors which impose a number of restrictions when used for continuous medical examination of citizens.

 

The ultrasound imaging method provides an indication only about liver morphological features, which change at stages II to IV of the disease, proving inefficient in early liver disease diagnosis.

 

MRI and CT diagnostic methods are very expensive. Standard techniques and visualization software allow assessing only morphological changes in the liver, but that does not provide a complete picture for early liver disease diagnosis. In addition, when auxiliary visualization methods, like contrasting substances, are used, the procedure cost will substantially increase.

 

 

The following types of elastography are utilized:

 

  • Strain elastography (RTE);
  • Shear wave elastography (ARFI);
  • Transient elastography (TE);

 

Strain elastography (RTE) is used in modern ultrasound scanners and is applied to diagnose diseases associated with the thyroid and mammary glands. This method is not suitable for liver examinations, as this organ is located deep in the abdominal cavity.

Shear wave elastography (ARFI) is a modern method which is increasingly used in the world healthcare industry to examine the liver using ultrasound machines. It has several advantages when compared to other non-invasive diagnostic methods. This mode is already widely used by many manufacturers, such as GE Healthcare, Philips, Siemens, and SuperSonic, but unfortunately, this method is not yet standardized, does not have an ARFI measurement quality scale, and each manufacturer uses its own interpretation. Shear wave elastography (ARFI) is 90% accurate due to the wavelength index averaging when tissue elasticity is assessed.

Transient elastography (TE) is the most recent technology. This method is unique because insignificant mechanical vibrations which precipitate transverse waves in the liver tissue allow increasing the measured volume by 100 to 200 times than using a biopsy procedure. Such waves are propagated and elasticity coefficient is measured using ultrasound technology. To generate waves, a specialized combined mechanical and ultrasound sensor is utilized. Generating a mechanical wave by such a sensor and knowing parameters and a wavelength beforehand, we can achieve 97% clinical accuracy

 

 

Using transient elastography (TE) technique with the FibroTouch device, the obtained data on the liver condition corresponds to stage F1 to F4 disease in the kPa and correlates with the histological fibrosis stage according to the METAVIR scale, as well as takes the IQR measurement quality and reliability scale into account.

 In addition, the system highly accurately controls the ultrasound signal attenuation parameter in adipose tissue and, based on the data obtained, calculates the quantitative UAP result in dd/m, which is used to assess the liver steatosis degree.

 

As of today, the FibroTouch device manufactured by HISKY MED is the most advanced device using transient elastography (TE) technique. The device boasts 135 technology patents and 76 international patents.

 

The system is presented in two versions:

  • The portable ultrasound system for non-invasive liver examination using FT-100 transient elastography (TE) method;

  • The ultrasound system for non-invasive liver examination using FT-1000 transient elastography (TE) method, combined with an ultrasound module used to assess the liver shape, position, and morphological changes in the organ.

 

 

The FibroTouch device can be utilized to screen, diagnose, control, and monitor the following liver diseases:

  • Non-alcoholic fatty diseases;
  • Alcoholic diseases;
  • Chronic hepatitis B;
  • Chronic hepatitis C;
  • Autoimmune diseases;
  • Primary biliary cirrhosis;
  • Biliary tracts diseases.

 

The FibroTouch device provides the advantageous possibility to simultaneously diagnose liver fibrosis and fatty hepatosis, using one specialized sensor for all types of patients – children, men, and women with the standard bodily constitution and obese patients.

 

The advantages of transient elastometry (TE) provided by the FibroTouch devices are listed below:

 

1. VERSATILITY:

  • The diagnostic sensor is suitable for all types of patients: children, men, and women with the standard bodily constitution and obese patients with different degrees of obesity;
  • Accurate data to diagnose the disease at an early stage;
  • The possibility to use the device to control the conducted therapy and assess its efficiency;
  • No additional overhead costs necessary to use the device;
  • Examinations take no more than 5 minutes.

 

2. ACCURACY:

  • The only device providing 97% accuracy;
  • Diagnostic reproducibility with no more than 3% deviation in the results when the same patient is repeatedly examined;
  • WFUMB and EFSUMB (the World and European Federations for Ultrasound in Medicine and Biology) recommendations, as well as EASL (the European Association for the Study of the Liver) recommendations on transient elastography (TE) application in clinical examinations and diagnostics;
  • The measured volume is 100 to 200 times larger than with liver biopsy.

 

3. SAFETY:

  • The non-invasive technique, where patients more willing agree to undergo examinations;
  • The generally accepted diagnostic method in the USA, Europe, and China to reveal patients in need of liver disease treatment, which makes the method economically viable and competitive when compared to a biopsy procedure;
  • The IQR measurement quality and reliability scale maximally protects the operator from making a mistake;
  • The method is fully standardized and depends on the operator to the least extent possible, and this feature allows the system to be used not only by ultrasound therapists but by any other medical professionals;
  • The assessed volume includes exclusively the liver structure, and that allows operators to maximally avoid false positive or negative results;
  • Automatic and instant report with standardized F1-F4 parameter for the fibrosis stage according to the METAVIR scale and fatty liver degeneration stage assessment.

 

Where to buy FibroTouch?

 

Medford Medical Solutions Co., Ltd. is HiSky’s representative office and the first distributor of the FibroTouch device to the Russian market. Offices are available in Moscow, St. Petersburg, and Sevastopol. The company has been supplying medical diagnostic equipment since 2009 and currently also provides servicing and technical support for high-tech medical equipment.

29.01.2019