FDA clears Aixplorer’s Real-Time ShearWaveTM Elastography

 FDA clears Aixplorer’s Real-Time ShearWave™ Elastography

(SWE™) to truly quantify tissue elasticity.

Revolutionary ultrasound imaging system for breast, liver, thyroid, prostate and other organs

enables electronic palpation that displays real-time, quantitative (kPa) tissue elasticity on a

color-coded map, aiding physicians in their diagnostic process as tissue stiffness varies

with pathologies.

Aix en Provence, France, (September 30, 2013) SuperSonic Imagine, the highly

innovative company which invented ShearWave™ Elastography, announced today that the

Aixplorer® MultiWave™ Ultrasound system, first cleared by the FDA in 2009, has now

received FDA clearance for the quantification capabilities of its Real-Time ShearWave™

Elastography (SWE™).

Aixplorer’s UltraFast™ imaging platform images up to 200 times faster than conventional

ultrasound, making it the only system in the world that can, in real-time, generate shear

waves in tissue and simultaneously image and compute the velocity of these waves.

Since shear wave velocity is directly related to tissue stiffness, ShearWave Elastography is a

technological breakthrough in medical imaging as it permits noninvasive electronic

palpation, even in deep, hard to reach organs.

This electronic palpation displays real-time, quantitative (kPa) tissue elasticity on a colorcoded

map and aids physicians in their diagnostic process, as tissue stiffness varies with

the severity of pathology.

ShearWave Elastography imaging also provides additional clinical advantages for

ultrasound-guided procedures, evaluation of multifocal stiff tissue, dynamic analysis of

elasticity changes and longitudinal follow-up of tissue abnormalities and treatment.

“The clearance of this unique quantification tool for our real-time elastography technology is

the result of a close and proactive interaction between the FDA and the company, to

substantiate scientific evidence of our product performance,” said Claude Cohen-Bacrie,

Executive Vice President of SuperSonic Imagine. “ShearWave Elastography has been used

around the world since 2009 and there are over 50 major publications in several different

organs, supporting the clinical benefits of this technique as an adjunct to ultrasound

imaging. SWE™ has been studied extensively in the breast and a large, multicenter clinical

trial has demonstrated its added value for lesion characterization.* In addition, ShearWave

Elastography allows the user to locate stiff nodules in multi-nodule thyroid goiters, to assess

the different stages of fibrosis in the liver and to visualize stiff areas in the peripheral zone of

the prostate. We are thrilled that American physicians now have access to this invaluable

diagnostic tool and we believe the clinical benefits of the Aixplorer will strengthen their

medical practices,” he continued.