IMRIS obtains CE mark for first ceiling-mounted intraoperative CT solution


IMRIS has announced that it has obtained regulatory CE mark for VISIUS iCT, the first and only ceiling-mounted intraoperative computed tomography, allowing for sales and marketing in the European Union, according to a company release.

“This is another step in our overall global launch after recently receiving clearance from the FDA,” said Jay D Miller, IMRIS CEO and President. “European Union spine surgeons now have the opportunity to use this unique solution in confirming implant placements, fusion and other complex procedures. As procedures become more minimally invasive, the need for better visualisation with advanced imaging increases. Both US and European spine surgeons will be especially interested in the outstanding dose management capabilities and state-of-the-art image quality available with VISIUS iCT.”

IMRIS received US Food and Drug Administration (FDA) 510(k) clearance for VISIUS iCT on 18 July. The company now has systems sold to three major eastern US neurosciences centres with installations in progress at two of these centres, according to the release.

VISIUS iCT provides personalised dose management together with diagnostic-quality imaging during surgical procedures to assist surgeons in critical decision making and procedure guidance. The 64-slice scanner can move into and out of the operating room in about 30 seconds during surgery using ceiling-mounted rails to ease workflow. The scanner can travel into two adjacent operating rooms to allow the hospital to use it for more patients.

Patient transport and need for floor-mounted rails used by other systems are eliminated which opens up valuable OR space and allows unimpeded movement of surgical equipment and maintaining familiar surgical protocols, workflow and infection control procedures. Portable CT systems deliver lesser image quality. The VISIUS iCT also offers the longest scanner travel range on the market today, it said in the press release.

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 maximise image quality and minimise dose. The system software allows dosage visualisation prior to the scan and adjustments based on specific clinical need with detailed dosage reports produced after each scan.