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SuperSonic Imagine Announces FDA Clearance For Aixplorer Ultrasound System

SuperSonic Imagine, a unique ultrasound system developer, has received FDA 510(K) approval for Aixplorer ultrasound system. This approval will allow SuperSonic Imagine to market the device in US. The device is incorporated with MultiWave Technology, which is based upon interaction between conventional longitudinal waves and shear waves in tissue. The system features all software-based architecture which offers both impeccable B-mode images and, also displays tissue stiffness or elasticity information using shear waves. This tissue characterization ability will enhance the diagnostic information.

Aixplorer’s SonicSoftware, the power behind MultiWave Technology, has benefited from a combination of the most advanced technology in the graphic games industry and the latest generation of multi-core processors to provide a complete ultrasound system with enhanced speed, accuracy and flexibility. The effect of this innovation is superior B-mode image clarity and an open door to new imaging modalities.

Speed, accuracy and flexibility play a large role in what many regard as Aixplorer’s B-mode image quality. It brings fundamental improvements to traditional imaging by software that improves conspicuity, lateral and contrast resolution and delineation of structures to better characterize tissue. MultiWave imaging also supports TissueTuner, a unique tool that allows the user to adjust the system’s parameters to accurately match the speed of sound in the tissue being imaged.

Since we introduced Aixplorer there has been a great deal of anticipation for its FDA approval, said Jacques Souquet, PhD, President of the Aix-en-Provence, France based company. Clinical investigators in the US and globally report that the system provides clinical efficacy in better characterization of lesions. Based on their findings many regard Aixplorer’s B-mode capabilities and ShearWave Elastography as the next level and future of ultrasound, he asserted.

Dr. David Cosgrove, Emeritus Professor of Clinical Ultrasound at Imperial College London and one of several clinical investigators across fifteen global sites using prospective formal protocols stated: We have had the opportunity to compare it with several reference systems for breast imaging. Time-and-again the Aixplorer images were more revealing, with cleaner, lower noise images and crisper margins to normal structures and lesions.

New imaging modalities have surfaced as Aixplorer presents its patented ShearWave Elastography. While shear waves naturally exist in the human body, SuperSonic Imagine’s development of new MultiWave ultrasound technology produces images which leverage the interaction between longitudinal waves or B-Mode with shear waves. Aixplorer can generate, capture and compute shear wave velocity resulting in the bi-dimensional display of true tissue elasticity.

ShearWave Elastography is different from conventional or strain elastography which relies on manual compression for palpation and is therefore subjective and operator dependent. Instead, ShearWave Elastography is user-skill independent as it does not rely on compression but is based on the simultaneous use of both ultrasound waves and shear waves to assess tissue stiffness. ShearWave Elastography uses remote palpation to provide an objective assessment of tissue stiffness in real time using color-coded mapping. In addition, results are reproducible and lesions can be monitored over time.

With UltraFast Imaging, Aixplorer can acquire data at speeds of up to 20,000 Hz which is 200 times faster than conventional ultrasound.

The significance of this technology was emphasized by Ellen Mendelson, MD, Professor of Radiology at the Feinberg School of Medicine, Northwestern University, who suggested: We expect Supersonic Imagine’s ShearWave Elastography, which does not require manual compression, to augment the specificity of breast ultrasound examinations. This novel technology enables measurements of tissue stiffness to be obtained in seconds, easily and reproducibly using the same transducer to depict the B-mode BI-RADS features of benign and malignant breast masses.

Aixplorer offers clinical performance and patient management advantages such as, Improved lesion characterization through clarity, improved conspicuity, and better delineation of normal and abnormal structures, Sharper borders and superior lateral and contrast resolution in different tissue densities from fatty to dense, Simultaneous impeccable resolution while in B-mode, Color and Power DopplerImaging in ShearWave Elastography displaying local tissue elasticity in real time, Reproducible results that can be tracked over time, User skill independence, Time-saving easy upgrades of software, Easy reporting with software-integrated BI-RADS, Intuitive ergonomic design for comfort and ease of use.

The company received its CE mark in early 2009 and has been put to work in clinics throughout Europe.