E-Z-EM Receives FDA 510(k) Clearance for EmpowerMR Injector System
April 16 2007 - 12:45PM
Business Wire
E-Z-EM, Inc. (NASDAQ:EZEM) today announced that the Company has
received 510(k) clearance from the Food and Drug Administration
(FDA) for its EmpowerMRTM injector system�the Company�s first
product for the magnetic resonance (MR) imaging market. Building on
the Company�s successful Empower family of CT injector systems,
EmpowerMR has the same easy-to-use interface and robust safety
features as the other products in the Empower injector line.
EmpowerMR also employs several innovative features designed to cope
with the problem of electrical interference in the magnetic field
of the MR scanner. Magnetic resonance imaging systems operate by
detecting minute variances in the alignment of molecules within
certain tissues of the human body. To detect these variances, MR
systems create powerful magnetic fields, and require the use of
non-magnetic materials and components in the immediate surroundings
of the scanner. Electromechanical devices like injector systems can
create both electric and magnetic fields that cause electrical
interference with the scanner during the imaging process, leading
to image distortion or artifacts. To minimize this problem,
EmpowerMR employs a unique, patent-pending hydraulic control system
instead of the shielded electrical control components used by most
other MR injectors systems. EmpowerMR has no shielded iron core
motors, piezoelectric motors or electrically active motor control
circuitry adjacent to the scanner, which significantly minimizes
the prospect of electrical interference with the scanner�s magnetic
field. EmpowerMR provides for utilization in MR field strengths up
to 7 Tesla. EmpowerMR is also not battery operated, and links to
its electrical supply by a single pass-through cable that does not
require special shielding. As there is no motor in the MR suite,
EmpowerMR does not generate audible noise. EmpowerMR�s hydraulic
control also means the system can deliver consistent flow rates,
volumetric and pressure performance on demand�features which may
help improve productivity in the MR suite. According to recent data
from IMV Limited, a medical technology market analysis firm, there
are approximately 6,000 MR scanners in the United States and
approximately 15,000 worldwide. Currently, approximately 20% of MR
procedures involve the use of injected contrast. Commenting on the
announcement, Anthony A. Lombardo, President and Chief Executive
Officer, �EmpowerMR is a natural addition to our family of injector
products, and offers the same feature set and interface that made
our Empower line an award winner. With its unique hydraulic control
systems, we believe it is one of the most innovative injector
systems available to the imaging market, and when coupled with our
IRiSMRTM data management software, EmpowerMR will provide superior
injection data management capability as well. We look forward to
formally launching EmpowerMR in the coming weeks and for the
product to be a contributor to sales in our next fiscal year.�
About E-Z-EM, Inc. E-Z-EM is a leading manufacturer of contrast
agents for gastrointestinal radiology. The Company is the developer
of VoLumen��the next generation low density barium sulfate
suspension for use as an oral contrast in Multidetector CT (MDCT)
and Positron Emission Tomography (PET/CT) studies. The Company also
offers Empower�?the only family of CT injectors on the market with
patented EDA� technology that can help detect contrast
extravasation?and offers a complete product set for the virtual
colonoscopy practitioner. This product line consists of virtual
colonoscopy hardware, software, nutritional prep kits and bowel
cleaners, tagging agents and a carbon dioxide colon insufflation
system. The Company is also the exclusive world-wide manufacturer
and marketer of RSDL for first-responder organizations and military
services. RSDL is a patented, broad spectrum liquid decontaminant,
that neutralizes and/or removes chemical warfare agents and T-2
toxins from skin. The statements made in this document contain
certain forward-looking statements. Words such as �expects,�
�intends,� �anticipates,� �plans,� �believes,� �seeks,� �estimates�
or variations of such words and similar expressions, are intended
to identify such forward-looking statements. The forward-looking
statements contained in this release may involve numerous risks and
uncertainties, known and unknown, beyond the Company�s control.
Such risks and uncertainties include: the ability of the Company to
develop its products; successful launch, market acceptance and
future sales of Empower MR injector systems, market acceptance and
sales of VoLumen�; future actions by the FDA or other regulatory
agencies, overall economic conditions, general market conditions,
price increases of raw materials and components, foreign currency
exchange rate fluctuations as well as the risk factors listed from
time to time in the SEC filings of E-Z-EM, Inc., including but not
limited to its Annual Report on Form 10-K for the fiscal year ended
June 3, 2006 and its 10-Q for the quarter ended March 3, 2007.
Consequently, actual future results may differ materially from the
anticipated results expressed in the forward-looking statements,
and investors are cautioned not to place undue reliance on the
forward-looking statements included in this release.
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