IMRIS receives Australian regulatory clearance for intraoperative CT solution
VISIUS iCT listing expands availability of state-of-the-art imaging with
low dose management accessed effortlessly in the OR
MINNEAPOLIS, MN, Feb. 26, 2014 /PRNewswire/ – IMRIS Inc. (NASDAQ: IMRS; TSX:
IM) (“IMRIS” or the “Company”) today announced that it has obtained
Therapeutic Goods Administration (TGA) regulatory listing for VISIUS(® )iCT, the first and only ceiling-mounted intraoperative computed
tomography, allowing for sales and marketing in Australia.
“This is another step in our overall global launch following US and
European approvals. VISIUS iCT offers the highest image quality of
competing intraoperative systems along with market leading dose
management capabilities,” said Jay D. Miller, IMRIS CEO and President.
“As procedures become less invasive, the need for better visualization
with advanced imaging during procedures and low radiation exposure
increases. With this unique solution, surgeons can confirm implant
placements, fusion and other complex procedure results while still in
Market research shows that Australia is the second fastest growing
spinal implant market behind China in the Asia Pacific region with a
compounded annual growth rate of 8.4 percent since 2003. Australia is
also the third largest contributor of medical imaging equipment sales
in the area.
The Company currently has two Australian customers with VISIUS
intraoperative MRI (iMRI) installations at Royal Children’s Hospital in
Melbourne and Canberra Hospital in Canberra. In 2013, IMRIS established
an office in Singapore to increase focus on the growing Asia Pacific
IMRIS received U.S. Food and Drug Administration (FDA) 510(k) and CE
mark clearance for VISIUS iCT in July 2013. The Company now has several
systems sold to major US neurosciences centers.
VISIUS iCT provides personalized dose management together with
diagnostic quality imaging during surgical procedures to assist
surgeons in critical decision support and procedure guidance. The
64-slice scanner effortlessly moves into and out of the operating room
(OR) in about 30 seconds during surgery using ceiling-mounted rails to
ease workflow. In addition, IMRIS offers a configuration where the
scanner can travel into two ORs to allow the hospital to use it for
Use of VISIUS iCT does not require patient transport or need for
floor-mounted rails like other CT systems which opens up valuable OR
space and provides unimpeded movement of surgical equipment. The
surgical team can maintain familiar surgical protocols, workflow and
infection control procedures. Portable CT systems on the market deliver
lesser image quality. The VISIUS iCT also offers the longest scanner
travel range on the market today.
Minimizing radiation dose is critical. VISIUS iCT features a suite of
software applications such as 3D volume rendering to aid in surgical
planning and dose reduction algorithms which consider a patient’s
unique characteristics and imaging target to maximize image quality and
minimize dose. The system software also offers state-of-the art dose
tools like iterative reconstruction and real-time dose (kV and mAs)
IMRIS (NASDAQ: IMRS; TSX: IM) is a global leader in providing image
guided therapy solutions through its VISIUS Surgical Theatre – a
revolutionary, multifunctional surgical environment that provides
unmatched intraoperative vision to clinicians to assist in decision
making and enhance precision in treatment. The multi-room suites
incorporate diagnostic quality high-field MR, CT and angio modalities
accessed effortlessly in the operating room setting. VISIUS Surgical
Theatres serve the neurosurgical, spinal, cardiovascular and
cerebrovascular markets and have been selected by 57 leading medical
institutions around the world.
SOURCE IMRIS Inc.