IMRIS Receives CE Mark Approval for Interventional Imaging System
WINNIPEG, April 30 /PRNewswire-FirstCall/ - IMRIS Inc. (TSX: IM - News; "IMRIS" or the "Company") today announced CE Mark approval for its integrated MR imaging and x-ray angiography suite that enables physicians to diagnose, intervene, resolve and confirm the effectiveness of treatment with one integrated system. With CE Mark approval, IMRIS will immediately commence marketing in Europe of two products: IMRISNV for stroke management and advanced neurovascular interventions and IMRIScardio for cardiovascular interventions.
IMRISNV features a 3T MRI scanner and a bi-plane angiography system specifically designed to co-exist in the same suite. Patients with acute ischemic stroke transition seamlessly from MR imaging to intervention without moving from the table. During and after the intervention, new MR images can be taken to assess the effectiveness of the treatment. IMRISNV is designed to shorten transition time between imaging modalities, decrease the overall time for treatment and improve patient outcomes.
IMRIScardio features a 1.5T MRI scanner that provides images that can improve the physician's ability to visualize the cardiovascular system before, during and after an intervention. With an integrated single-plane angiography system, IMRIScardio is designed to improve patient outcomes by decreasing the overall time for cardiovascular interventions and minimizing the patient's exposure to radiation and contrast media.
"CE Mark approval of our system represents our first step into the realm of neurovascular and cardiovascular interventional imaging", stated David Graves, CEO of IMRIS. "We are excited about launching our technology in Europe and we are confident that IMRISNV and IMRIScardio will help physicians and hospitals improve the outcomes of their patients suffering from a wide range of neurovascular and cardiovascular conditions."
About CE Mark
The CE Mark for medical devices is not a quality mark nor is it intended for consumers. It is a legally binding statement by the manufacturer that their product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVD 98/79/EC) or the Active Implantable Medical Device Directive (AIMD 90/385/EEC), where applicable.
About IMRIS
IMRIS (TSX: IM - News) is a global leader in providing fully integrated, advanced surgical imaging solutions. The company's flagship product, IMRISneuro, utilizes patented technology that allows a high field MRI scanner to be moved in to the operating room on demand, providing imaging during the surgical procedure without compromising patient safety. This unique and innovative system has been validated by leading neurosurgeons for use in world-class neuroscience centers. For more information, visit www.imris.com.