Surgical theater gets FDA clearance

Surgical theater gets FDA clearance

Next-generation surgical theatre deliver on-demand access to real-time data and state-of-the-art imaging, during the procedure from the OR table.

February 20, 2014
Manufacturing Group
Industry/Regulations Contract Manufacturing Design/Engineering Devices/Implants/Equipment People/Facilities

Minnetonka, Minn. - IMRIS has received the U.S. Food and Drug Administration (FDA) clearance for its next-generation VISIUS surgical theater equipped with Siemens' latest high-field MR scanners.

Using Siemens Aera 1.5T (tesla) and Skyra 3.0T technology the IMRIS deliver better image quality with higher signal-to-noise ratio, faster 3D image acquisition, and improved ease-of-use and workflow during neurosurgical procedures using intraoperative MRI (iMRI).

IMRIS president and CEO Jay D Miller said: "We are bringing the latest and unequalled imaging technology into the operating room where it can make the most difference during the surgery.

"IMRIS systems have been used in more than 13,000 cases worldwide to improve outcomes in brain tumor and epilepsy surgeries in particular."

The addition of these MR systems expands the 1.5T and 3.0T MRI choices hospitals have when considering the unique, ceiling-mounted IMRIS solution for intraoperative imaging which brings the MRI to the patient during the procedure.

The first installation of this new generation VISIUS Surgical Theater will be a four-room hybrid operating room suite, known as the Center for Surgical Innovation (CSI) at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

Dartmouth - Hitchcock medical director of CSI and chair of orthopaedics Dr Sohail Mirza said: "The advanced integration of state-of-the-art imaging tools in CSI will allow surgeons and engineers to innovate like never before, rapidly developing, testing, and validating new surgical tools and techniques, with the goal of achieving better, safer, and, in some cases, less-costly care for patients everywhere."

The Dartmouth - Hitchcock installation will also include a VISIUS intraoperative CT (iCT), which uses the technology of the 64-slice Siemens SOMATOM Definition AS scanner, making it the only operating suite in the world with both VISIUS iMRI and iCT modalities able to serve multiple operating rooms (ORs) without moving the patient.

IMRIS also designs and manufactures proprietary head fixation devices, imaging coils, and OR tables for use in this unique and multifunctional intraoperative environment.

Source: IMRIS