ShearWave Elastography Ultrasound Provides New Diagnostic Capabilities in the US Healthcare Market

An innovative ultrasound technology is a one of a kind system with MultiWave technology, which is based upon interaction between conventional longitudinal waves and shear waves in tissue. The system consists of an all software-based architecture that provides both excellent B-mode images, and for the first time, displays tissue stiffness or elasticity information using shear waves. As stiffness is an additional parameter that characterizes tissue, the technology brings clinicians significantly enhanced diagnostic information.

SuperSonic Imagine (Aix-en-Provence, France) reported that it has received 510K clearance from the U.S. Food and Drug Administration (FDA) for its Aixplorer ultrasound system and will begin to market and deliver the device in the United States. Aixplorer's SonicSoftware, the power behind MultiWave technology, has ingeniously benefited from a combination of advanced technology in the graphic games industry and the latest generation multi-core processors to provide an ultrasound system with enhanced speed, accuracy and flexibility. The effect of this advance is superior B-mode image clarity and a doorway into new imaging modalities.

Speed, accuracy, and flexibility play a large role in what many regard as Explorer'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 match effectively 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, Ph.D., president of SuperSonic Imagine. "Leading clinical investigators in the United States and globally, report that the system provides exceptional 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 (UK) and one of several clinical investigators across 15 global sites using prospective formal protocols stated, "The B-mode quality on Aixplorer is superlative. 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 that utilize the interaction between longitudinal waves or B-Mode with shear waves. Aixplorer is the only system available that can generate, capture, and compute shear wave velocity resulting in the bidimensional display of true tissue elasticity.

ShearWave Elastography is different from conventional or strain electrograph, 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 it 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. Moreover, results are reproducible and lesions can be monitored over time.

Providing local tissue elasticity information in real time called for major technologic breakthroughs in the ultrasound medical imaging field. Capturing shear waves in tissue requires acquisition rates of at least 5,000 Hz while traditional ultrasound acquisition speeds are approximately 100 Hz. 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, M.D., professor of radiology at the Feinberg School of Medicine, Northwestern University (Chicago, IL, USA), who suggested that, "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 including improved lesion characterization through clarity, improved conspicuity, and clearer delineation of normal and abnormal structures; it has sharper borders and superior lateral and contrast resolution in different tissue densities from fatty to dense; offers simultaneous resolution while in B-mode, color, and power Doppler; presents imaging in ShearWave Elastography displaying local tissue elasticity in real time; provides reproducible results that can be tracked over time; offers user skill independence, time-saving easy upgrades of software, easy reporting with software-integrated BI-RADS, and intuitive ergonomic design for comfort and ease of use.

The company received its CE marking in early 2009, and has been put to work in clinics throughout Europe and selected countries of Asia. SuperSonic Imagine is a multicultural company focused on providing advanced technology to improve medical diagnosis.

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