IMRIS Inc. 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 biplane 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 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.