WINNIPEG, Sept. 8 /CNW/ - IMRIS Inc. (TSX: IM) ("IMRIS" or the "Company")
today announced that it has received 510(k) clearance from the US Food and
Drug Administration (FDA), permitting the Company to market its newest
products, IMRISNV and IMRIScardio in the United States.
IMRISNV and IMRIScardio are the first systems in the world to allow the
capabilities of both MRI and x-ray angiography in a single suite without the
need to transport the patient between modalities.
Neurovascular diseases including acute ischemic stroke require rapid
assessment and treatment. IMRISNV features a wide bore 3T MRI scanner and a
bi-plane angiography system completely integrated into a single suite that
permits the patient to transition quickly and seamlessly between MR imaging
and intervention without transporting the patient between modalities. Using
IMRISNV, MR images can be taken before and during procedures to assess tissue
health, and can also be used in conjunction with the fluoroscopic images
during the interventional procedure. On completion of the procedure, new
images can be taken to evaluate the intervention.
Cardiovascular interventions demand a high level of accuracy in the
diagnosis of patients and in the assessment of treatments. IMRIScardio
provides physicians with enhanced images for visualizing the cardiovascular
system before, during and after an intervention. The IMRIScardio suite
includes a wide bore 1.5T MRI scanner and a single-plane or bi-plane
angiography system providing the ability to alternate between imaging
modalities and immediately assess treatment.
IMRISNV and IMRIScardio are available in multiple room configurations to
provide diagnostic, interventional and surgical capabilities, which
significantly enhance the utilization of equipment and space for hospitals.
"The addition of IMRISNV and IMRIScardio expands our product portfolio
and the scope of our market opportunity considerably," said David Graves,
President & CEO. "FDA clearance for these products is a major milestone for
IMRIS as we continue to develop innovative image guided solutions for use in
leading hospitals around the world."
The Company received CE Mark regulatory approval in Europe for IMRISNV
and IMRIScardio earlier this year, and an application is currently pending
with Health Canada.
IMRIS (TSX: IM) is a global leader in providing fully integrated,
advanced imaging solutions that incorporate multiple imaging modalities
including magnetic resonance and fluoroscopy to deliver timely information to
clinicians during surgical or interventional procedures. The Company's systems
utilize patented technology that allows a high field MR scanner to be moved in
to the operating room on demand, providing imaging during the surgical or
interventional procedure without compromising patient safety. The Company's
flagship product, IMRISneuro, has been validated by leading neurosurgeons and
is in use at neuroscience centers around the world.
For further information:
For further information: Media: Michael Robbie, Director Marketing,
IMRIS Inc., Tel: (204) 480-7696, Email: firstname.lastname@example.org; Investors: Brad
Woods, Director Investor Relations & Corporate Communications, IMRIS Inc.,
Tel: (204) 480-7094, Email: email@example.com