AIX-EN-PROVENCE, France--(BUSINESS WIRE)--Regulatory News:
SuperSonic Imagine (Euronext: SSI, FR0010526814) (Paris:SSI), a company specializing in ultrasound medical imaging, announced today that it will feature the Aixplorer® platform at Digestive Disease Week (DDW) 2018, held June 2 – 5 at Walter E. Washington Convention Center in Washington, D.C. The Aixplorer platform, which includes the Aixplorer and Aixplorer Ultimate ultrasound systems, is the only imaging ultrasound device platform to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) to aid clinical management of adult patients with liver disease. The technology gives physicians new validated clinical indicators to support non-invasive assessment of hepatic fibrosis and steatosis.
“To use an accurate, non-invasive, 60-second imaging test instead of a biopsy is a groundbreaking change for hepatologists who treat liver disease and millions of patients who suffer from it,” said Dr. Sumeet Asrani MD MSc, Baylor University Medical Center, Dallas, Texas. “Millions of Americans are diagnosed with liver diseases each year, and tens of thousands die.1 A non-invasive alternative can help patients avoid repeated biopsies, as well as lower the threshold for that level of testing. It is truly exciting.”
In addition to routine morphological and hemodynamic imaging, Aixplorer systems can quickly and reliably image and measure liver and spleen stiffness in real time under image guidance, utilizing the platform’s ShearWaveTM Elastography (SWE) technology, a 60-second non-invasive exam. Liver and spleen stiffness are known to be correlated to liver fibrosis severity and are therefore considered critical non-invasive bio markers of disease severity. Physicians also can compare ultrasound liver brightness to reference tissue to gain a hepato-renal brightness ratio, which indicates the extent of hepatic steatosis. Aixplorer’s ability to visualize and quantify abdominal vascularization and perfusion aid clinical management of adult patients with liver nodules and advanced chronic liver diseases as well.
“We think it’s appropriate to feature the Aixplorer Ultimate’s capabilities for liver disease at this DDW 2018 meeting, which is themed, ‘Monumental Developments in Science and Medicine,’” said Michèle Lesieur, CEO of SuperSonic Imagine. “We are very proud of the 510(k) clearance we received in January, which made the Aixplorer platform the only imaging ultrasound device specifically approved for management of liver disease, and we look forward to sharing its capabilities with esteemed specialists from around the world.”
SuperSonic Imagine will be exhibiting during DDW 2018 in the Exhibit Hall at booth #2046.
About SuperSonic Imagine
Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is a company specializing in medical imaging. The company designs, develops and markets a revolutionary ultrasound system, Aixplorer®, with an UltraFast™ platform that can acquire images 200 times faster than conventional ultrasound systems. In addition to providing exceptional image quality, this unique technology is the foundation of several innovations which have changed the paradigm of ultrasound imaging: ShearWave™ Elastography (SWE™), UltraFast™ Doppler, Angio PL.U.S – Planewave UltraSensitive™ Imaging and more recently TriVu. ShearWave Elastography allows physicians to visualize and analyze the stiffness of tissue in a real-time, reliable, reproducible and non-invasive manner. This criteria has become an important parameter in diagnosing potentially malignant tissue or other diseased tissue. As of today, over 400 peer-reviewed publications have demonstrated the value of SWE for the clinical management of patients with a wide range of diseases. SuperSonic Imagine has been granted regulatory clearances for the commercialization of Aixplorer in key global markets. SuperSonic Imagine is a listed company since April 2014 on the Euronext, symbol SSI. For more information about SuperSonic Imagine, please go to www.supersonicimagine.com.
1. CDC/National Center for Health Statistics: Chronic Liver Disease and Cirrhosis. October 6, 2016. (https://www.cdc.gov/nchs/fastats/liver-disease.htm).