INTERPRETATION GUIDE Quantifying steatosis with FibroScan Combined with Liver Stiffness, CAP is the only non-invasive CAP and 1H-MRS: similar diagnostic performance [1] examination to genuinelyquantify steatosis in Non-Alcoholic Fatty CAP 1H-MRS Liver Disease (NAFLD) and other chronic liver diseases associated S ≥ 5% AUC 0.93 0.87 with steatosis and fibrosis S ≥ 34% AUC 0.94 0.88 The existing literature demonstrates that CAP values correlate with S ≥ 67% AUC 0.82 0.85 the amount of steatosis, metabolic syndrom and alcohol use Valuable insights for following up patients post treatment Early detection of minimalhepatic steatosis:from 5% onwards (demonstrated in more than 3 studies) (Ultrasound allows to detect from 30% only) CAP not influenced by fibrosis and inflammation (demonstrated in more than 7 publications) Meta-analysis (n=2735, 19 studies) [2] Liver histology-determined steatosisS 0 = 0-4/10%S1 = 5/11-33%S2 = 34-66%S3 = 67-100% NAFLD/NASH (n=65) [1] S 0 = 0-4% S1 = 5-33%S2 = 34-66% S3 = 67-100% Chronic Hepatitis C (n=615) [3] S 0 = 0-4% S1 = 5-33%S2 = 34-66% S3 = 67-100% Chronic Hepatitis B (n=189) [4] S 0 = 0-10% S1 = 11-33%S2 = 34-66%S3 = 67-100% CAPTM (dB/m) 200 250 300 350 400 | | 248 dB/m 280 dB/m Peer-reviewed publications per LSM and CAP interpretation Guides etiology available on myFibroScan app Non-related liver diseases Follow up 9,5 % of interventions 5 % NAFLD/NASH Diabetes General 49% population 7,5 % Viral Hepatitis 12,5 % Others NEW - FREE APP 10,5 % Alcoholic liver diseases 6 % [1] Karlas, T. and al., Non-invasive assessment of hepatic steatosis in patients with NAFLD using Controlled Attenuation Parameter and 1H-MR Spectroscopy. Plos One, March 2014, Issue 3, Volume 9. [2] Karlas, T., et al. Individual Patient Data Meta-Analysis of Controlled Attenuation Parameter (CAP) Technology for Assessing Steatosis. Journal of Hepatology 2016 ; In Press.[3] Sasso, et al., Novel controlled attenuation parameter for noninvasive assessment of steatosis using Fibroscan : validation in chronic hepatitis C. J Viral Hepat 2012 Apr;19(4):244-53. doi: 10.1111/j.1365-2893.2011.01534.x. Epub 2011 Oct 13. [4] Chen, et al., Controlled attenuation parameter for the detection of hepatic steatosis in patients with chronic hepatitis B. Infect dis. (Lond) 2016 Sep;48(9):670-5. doi: 10.3109/23744235.2016.1165860. Epub 2016 May 31. * Publications parues dans des revues à comité de lecture. Retrouvez toutes les publications relatives à l’élasticité et au CAP sur la Librairie Clinique Echosens : http://www.echosensclinicallibrary.com/ These guides are based on a selection of clinical studies from the existing literature reporting use of stiffness and CAP with FibroScan. These guides are not intended to be used as a conversion table from liver stiffness and CAP readings in kilopascals (kPa) and decibels per meter (dB/m) tofibrosis and steatosis grade. These guides can in no way replace the judgment of the physician who is ultimately responsible for the final diagnosis. Echosens accepts no responsibility for the incorrect and/or inappropriate interpretation of liver stiffness or CAP values. FibroScan® is a class IIa medical device according to Directive EC/93/42 and is manufactured by Echosens. CE mark is in progress. FibroScan® is indicated for the non invasive measurement of liver stiffness (E) and controlled attenuation parameter (CAP) in humans. It is expressly recommended to carefully read the guidance and instruction of the users’ guide and labeling of the device. Results obtained must be interpreted by a physician experienced in dealing with liver disease, taking into account the complete medical record of the patients. Our products are subject to regulatory requirements that vary from country to country and therefore may not be available for sale or distribution in all markets. 810250 GNE SEDIUG PAC MSL - SRETEMARAP lacinhcet & serutcip lautcartnoc-non - DEVRESER STHGIR LLA SNESOHCE THGIRYPOC © SKRAMEDART DERETSIGER ERA ,™snesohcE - 58431 OSI - 9540