18 US neurosurgeons from 9 leading institutions validate robot usability for final 510(k) submission deliverable
IMRIS Inc. (NASDAQ: IMRS; TSX: IM) ("IMRIS" or the "Company") today announced that the Company has successfully completed the human factors study for the SYMBIS® Surgical System – the comprehensive validation used to support the product's 510(k) submission to the U.S. Food and Drug Administration (FDA) on November 26.
"This is a significant step leading to our goals of merging intraoperative imaging with robotics," said IMRIS President and CEO Jay D. Miller. "By finding ways to enhance the vision and precision of surgery through technology, we are working towards improving the outcomes for patients with neurological disorders at lower costs for the healthcare system."
Human factors is the science of understanding how humans interact physically and psychologically with a device. For example, in aviation, an engineer can develop an instrument; however, if the engineer fails to account for how a pilot uses this instrument in the cockpit, then user errors may result even if the instrument did its job. Over the past eight years, the FDA has been actively working with companies to apply the science of human factors to medical device development.
The human factors study provided a neurosurgeon's perspective on how well use-related risks were mitigated by the IMRIS design team, when the SYMBIS Surgical System is used by neurosurgeons. The study physicians were asked to perform a planned simulated procedure without any outside intervention. Throughout the study, the subject's interaction with the system was observed for any use-related errors.
"The human factors study was not only an opportunity for IMRIS to validate the performance of the SYMBIS System with real users," Miller added, "we also captured the voice of the customer on how surgeons perceive the current system, as well as the future clinical applications where robotics in neurosurgery can provide both clinical and economic value."
The SYMBIS human factors study involved a diverse group of 18 neurosurgeons of varying demographics and range of neurosurgical experience. Subjects were recruited from nine leading neurosurgical centers in the US – including three centers that do not currently have a VISIUS® Surgical Theatre with intraoperative MRI (iMRI).
One of the study subjects, neurosurgeon Dr. William Broaddus of Richmond, VA, said, "During my career, I've been fortunate to take part in the early stages of a number of new technologies that have found valuable applications in neurosurgery. After working with the SYMBIS System as a human factors study subject, I see this technology as an exciting platform for major advances in neurosurgical practice."