IMRIS receives FDA clearance for new neurosurgical HFD rocker arm

Head fixation device (HFD) accessory provides skull stabilization for more patient head sizes

IMRIS Inc. (NASDAQ: IMRS; TSX: IM) ("IMRIS" or the "Company") today announced a new rocker arm accessory that expands choices for neurosurgeons to select the best fixation suited for patients during procedures using intraoperative imaging inside the VISIUS Surgical Theatre. The accessory recently received 510(k) clearance from the U.S. Food and Drug Administration.

The new rocker arm accessory provides more flexibility for the surgeon to stabilize, support and position patient heads with varying cranial anatomy, sizes and conditions using the MRI-compatible IMRIS HFD. When attached to the head fixation device (HFD) - a clamp-like device - the rocker arm helps to reduce the pressure on the individual contact points on the patient's skull.

"Providing these optimal tools for neurosurgeons will allow more patients to benefit from the value of diagnostic quality imaging in the operating room with VISIUS iMR," said Jay D. Miller, IMRIS President and CEO. "The development of the rocker arm is an example of IMRIS' ability to design products and features that allow neurosurgeons to use intraoperative MR inside the VISIUS Surgical Theatre for an expanding patient population."

Inside a VISIUS Surgical Theatre equipped with high-field intraoperative MRI (iMRI), surgeons have on-demand access to real-time diagnostic quality imaging during the procedure and from the operating room table as the scanner uniquely moves to the patient on ceiling-mounted rails. The IMRIS HFDs support the unique ability to limit patient movement or re-positioning and maintain optimal positioning for both surgical access and intraoperative imaging during neurosurgical procedures.

The VISIUS iMRI provides neurosurgeons the ability to assess and decide to perform further resection for removing as much tumor as possible by clearly visualizing tumor and healthy brain tissue which otherwise are hard to differentiate.




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