By Business Wire, September 30, 2013, 02:22:00 PM EDT
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
AIX EN PROVENCE, France--(BUSINESS WIRE)--
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 color-coded 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
Wendie Berg, MD PhD, Attending Radiologist and Investigator stated that,
"Being able to actually quantify tissue stiffness in kilopascals and in
a real-time imaging tool, gives clinicians very precise information
about the tissue they are scanning. In the case of breast imaging,
quantification brings us higher specificity to better evaluate lesions.
This translates into better lesion classification that can help avoid
some unnecessary biopsies. It can also help us to recognize the need for
a biopsy for what was thought to be a probably benign mass."
SuperSonic Imagine CEO and President Jacques Souquet added: "As an
innovative company, we are very proud to see the FDA recognition of the
clear benefits our disruptive technology brings to the medical
profession. Physicians have assessed the clinical value of real-time,
quantitative ShearWave Elastography on more than 700 Aixplorers
worldwide and have validated SuperSonic Imagine as the leader in shear
wave based ultrasound elastography."
SWE™ is an easy to use, user-skill independent, reproducible technique
that is available on ALL of Aixplorer's transducers and imaging
Aixplorer's real-time, quantitative ShearWave Elastography can be seen
at SRU in October, AASLD and the RSNA in November 2013.
About SuperSonic Imagine
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 mode 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®. Distribution agreements have been signed with
prestigious companies such as Hologic (Nasdaq :HOLX) for the breast
market in the U.S.A. and Canon (NYSE :CAJ) for Japan. SuperSonic
Imagine's distribution network has now more than 35 partners worldwide.
For more information about SuperSonic Imagine, please go to www.supersonicimagine.fr
* BE1 clinical study : ShearWave Elastography Improves the Specificity
of Breast Ultrasound: The BE1 Multinational Study of 939 masses. Berg WA
et al. Radiology 2012. Summary available here.
**Except the vascular application
Source: SuperSonic Imagine