<0> Precise, non-invasive measurements of liver stiffness (kPa) shifts diagnostic paradigm with potential to change medical procedures for 1 billion people with hepatitis B virus (HBV) and nearly 300 million with the hepatitis C virus (HCV) </0>
Aixplorer® Ultrasound System with ShearWave™ Elastography Offers A Quantitative, Non-Invasive, Pain Free Tool to Help Determine Liver Fibrosis Severity
SuperSonic Imagine, the highly innovative medical imaging company that invented ShearWave™ Elastography, has applied this revolutionary technology to liver imaging, possibly reducing the need for many biopsies. ShearWave Elastography is a non-invasive technique that is being used worldwide to visualize and quantitatively measure (in kilopascals) tissue stiffness across the different stages of fibrosis leading up to cirrhosis. As a general rule, liver stiffness increases with the severity of liver fibrosis, making it an important parameter to help physicians determine which kind of treatment is needed and when. This technique can also play an important role in monitoring therapy. ShearWave Elastography is available only on the Aixplorer ultrasound system and is the only real-time, ultrasound-imaging mode cleared by the FDA to measure and display tissue stiffness.
Liver biopsy has traditionally been considered the standard for assessing liver fibrosis severity but this invasive method has major drawbacks including significant incidence of morbidity, procedure and hospitalization costs, and clinical shortcomings as fibrosis is underestimated in 10-30% of the cases. In addition, because of the invasive nature, biopsy is not ideal for repeated follow-up exams.
With ShearWave Elastography, physicians can determine quantitative liver stiffness values in a non-invasive, easy-to-use exam, which can be safely repeated over time to follow disease progression or regression. This diagnostic information can trigger medical treatment, help to evaluate the progress and effectiveness of drug therapy, and provide regular and previously unavailable imaging monitoring for complications. When invasive procedures are called for, Aixplorer’s exceptional image quality has proven highly effective in helping hepatologists and radiologists with ultrasound guided liver procedures such as needle placement for biopsy and paracentesis.
“We use ShearWave Elastography in our clinic, on a clinical basis, with around 15 to 20 procedures per week,” said Dr. James Trotter, MD of Baylor University Medical Center in Dallas, Texas. “ShearWave Elastography is done identically to ultrasonography so it’s a very comfortable and simple exam for the patient and it takes only 30-90 seconds to perform. It gives us a qualitative and quantitative way to determine the degree of chronic liver injury our Hepatitis C patients have. We use it on a routine basis to help us make clinical decisions about how we treat patients and we think that by using this technique, we can cut down the number of biopsies by about half.”
According to SuperSonic Imagine CEO Jacques Souquet Ph.D. “Several clinical studies have concluded that ShearWave Elastography is an accurate, reproducible technique to assess liver disease. The impact of ShearWave™ Elastography in liver imaging, both in clinical and economic terms, cannot be underestimated. This technology will enable a major shift in patient management.”
SuperSonic Imagine will be present at the American Association for the Study of Liver Diseases (AASLD) from November 2nd-4th 2013 at the Walter E. Washington Convention Center, Washington D.C.
(1) The role of laparoscopy in the diagnosis of cirrhosis. Poniachik J, Bernstein DE, Reddy KR, Jeffers LJ, Coelho-Little ME, Civantos F, Schiff ER. Gastrointest Endosc. 1996 Jun;43(6):568-71.
(2) Accuracy of Real-Time Shear Wave Elastography for Assessing Liver Fibrosis in Chronic Hepatitis C: A Pilot Study, Hepatology, 2012, Ferraioli et al. University of Pavia, Italy.
(3) Reproducibility of real-time shear wave elastography in the evaluation of liver elasticity, European Journal of Radiology, 5989, 2012 Ferraioli et al. University of Pavia, Italy.
(4) Quantitative Elastography of Liver Fibrosis and Spleen Stiffness in Chronic Hepatitis B Carriers- Comparison between ShearWave Elastography and Transient Elastography with Liver Biopsy Correlation, Radiology, 2013 August, Leung Vy, et al. Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China
Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is an innovative, international company specializing in ultrasound medical imaging. The company designs, develops, and markets a revolutionary ultrasound system, Aixplorer®, with a unique ultrasound imaging technology, called MultiWave™ Technology. This technology allows Aixplorer® to be the only ultrasound system that images two types of waves to better characterize tissue; an ultrasound wave to ensure impeccable image quality and a shear wave, ShearWave™ Elastography, to compute and display true tissue stiffness in real time by acquiring images nearly 200 times faster than conventional systems. Aixplorer’s second innovation is UltraFast™ Doppler, the first technique to combine Color and Pulsed Wave Doppler into one.
In 2009, SuperSonic Imagine was granted 510(k) clearance by the Food and Drug Administration in the United States and CE mark in Europe for the marketing of Aixplorer®. SuperSonic Imagine’s distribution network has now more than 35 partners worldwide.
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