MEDICAL DEVICE INNOVATION - Medical Device Daily

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FDA approves Aixplorer for
novel cancer diagnostics
By JOHN BROSKY
Medical Device Daily European Editor
PARIS — A novel diagnostic tool for detecting and characterizing
tumors that promises to revolutionize screenings
for breast and prostate cancers has been cleared for
commercialization in the U.S..
SuperSonic Imagine (Aix-En-Provence, France)
reported it received 510(k) approval from the Food & Drug
Administration (FDA) for Aixplorer, an ultrasound system
that combines a high-end B-mode ultrasound with an innovative
shear wave modality capable of measuring tissue
stiffness or elasticity.
Shear wave is a sophisticated enhancement for the
tried-and-true medical exam technique called palpitation
where the doctor presses a patient’s skin to feel for stiffness
of a liver or a breast lump.
This first line exam is based on the good sense that
supple tissue is healthy and stiff tissue is not.
Shear wave technology takes the palpitation test to a
new level by providing quantifiable data to characterize the
tissue, which combined with high quality B-mode images,
enables radiologists to diagnose the nature of a tumor.
Current screenings for breast cancer, for example, rely
on X-ray exams followed by biopsies of any suspect tissue
to characterize and diagnose tumors.
Shear wave exams potentially could eliminate several
steps and costly imaging procedures by providing a onestep
detection and tissue characterization exam, enabling
physicians to more precisely target lesions requiring a
biopsy.
Such exams could reduce the number of biopsies,
another potential cost savings, and also provide more
immediate results for patients who today must wait weeks
to hear whether a suspected tumor is malignant or benign.
While several companies provide ultrasound elasticity
exams using a compression method, where the scanner
operator presses down on tissue to create a sonic wave to
measure tissue stiffness, Aixplorer is the only FDAapproved
device that produces a pulse with its transducers
to create the same effect (Medical Device Daily, March 13,
2009).
Jacques Souquet, the founder of SuperSonic, dismisses
the operator compression technique as highly dependent
on the skill level and experience of a given operator, and
therefore not clinically reliable as results are not reproducible,
even by the same operator with a second exam.
Compression ultrasound provides “only a global
assessment of deformation where shear wave pulse provides
a local assessment of specific lesion stiffness,” he
said.
A demonstration of the Aixplorer platform featuring
MEDICAL DEVICE INNOVATION 2010
the proprietary ShearWave, which renders tissue images
200 times faster than conventional ultrasound and produces
a color-coded map of breast lesions, was first given
at the Radiological Society of North America meeting in
Chicago in December, 2008.
“Since we introduced Aixplorer there has been a great
deal of anticipation for its FDA approval,” said Souquet, who
adds that “elastography is the next level and the future of
ultrasound,”
The market potential for Aixplorer in the U.S. is significant
according to Edward McClenny, Supersonic’s General
Manager for the Americas.
“We’ve talked to hundreds of doctors and sonographers
and it is the combination of a spectacular image quality
and the potential for ShearWave elastography that is
driving the excitement,” he said.
The company received its CE mark in early 2009 and
began shipping Aixplorer units in April.
“Our sales funnel has exceeded our expectations for
the first three months of this year and we are building up
the capacity to meet this kind of demand,” he told MDD.
SuperSonic is currently completing a study of breast
exams using shear wave across 15 medical centers, including
seven in the U.S. and 10 in Europe.
The endpoint for the study is to demonstrate the specificity
of the shear wave exam in detecting tumors.
“In the United States there are two million breast biopsies
performed each year, yet 80% of these biopsies return
negative results,” said Souquet.
“That is a heavy cost to the healthcare system so if we
are able to clinically demonstrate that we can reduce the
number of biopsies required, that could represent significant
savings,” he said.
Physicians at Hammersmith-Charring Cross Hospital
(London), who are participating in the Supersonic study,
estimate the reduction in biopsies could be as high as 50%,
he said, while partner hospitals in the U.S. are more conservative
saying it could be reduced by 30% to 40%.
“If we demonstrate the effectiveness for breast examinations
we plan to move on to the prostate and the liver,”
Souquet said.
Earlier this year, the French innovation funding agency
OSEO invested 8.5 million ($11 million) in a collaboration
between Supersonic and Paris-based Theraclion to develop
a novel treatment for hyperparathyroidism with real-time
imaging of the therapy.
The TUCE project (Traitement Ultrasonore Controllé
Elastrographie) combines Theraclion’s Thyrus stereotactic
targeting for HIFU (high-intensity focused ultrasound) with
the Aixplorer from Supersonic measuring tissue elasticity
(MDD, Feb. 12, 2009).
(This story originally appeared in the Aug. 27, 2009,
edition of Medical Device Daily)
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