IMRIS secures US FDA clearance to market ceiling-mounted intraoperative CT solution

22 July 2013 (Last Updated July 22nd, 2013 18:30)

IMRIS has received 510K clearance from the US Food and Drug Administration for its Visius iCT, a CT imaging solution for the spinal and neurosurgical markets.

ICT

IMRIS has received 510K clearance from the US Food and Drug Administration for its Visius iCT, a CT imaging solution for the spinal and neurosurgical markets.

A ceiling-mounted intraoperative computed tomography (iCT), Visius iCT serves as surgical theatre that not only offers personalised dose management but also diagnostic quality imaging when a surgical procedure is performed, which will help surgeons in taking critical decisions.

IMRIS CEO  David Graves noted that this solution will be an essential part of the hybrid operating room of the future, especially for the spinal and neurosurgical market.

"VISIUS iCT provides surgeons with on-demand CT imaging to enhance decision making, and both guide and confirm implant placement," Graves said.

"The spine surgery market represents a new opportunity for IMRIS and VISIUS iCT establishes a level of intraoperative imaging previously unavailable to surgeons and patients."

Equipped with a 64-slice scanner, VISIUS iCT, using ceiling-mounted rails, can easily move into and out of the operating room during surgery, which will ease workflow.

This system allows multiple room configurations in order to meet clinical requirements, and also boost utilisation without affecting the exam speed or quality of images.

"The spine surgery market represents a new opportunity for IMRIS and VISIUS iCT establishes a level of intraoperative imaging previously unavailable to surgeons and patients."

In addition, transport of patients and requirement for floor-mounted rails as found in other systems are eliminated, opening up OR space and enabling unrestricted movement of surgical equipment and infection control in a simplified way.

The company claims that its system currently provides the longest scanner travel range in the market.

VISIUS iCT also comes with a group of software applications such as 3D volume rendering that help in surgical planning and dose reduction based on every patient's individual characteristics.

"State-of-the-art dose management is one of the keys to driving the adoption of iCT to guide surgical procedures," Graves added.

Its software enables physicians to visualise dosage even before the scan and adjust settings depending on the particular clinical requirement.


Image: VISIUS iCT, a ceiling-mounted intraoperative CT solution. Photo: courtesy of CNW Group/IMRIS Inc.