Medtronic Inc announced the commercial release of the NIM-Spine System neural integrity monitor, a surgeon-guided device for locating and identifying peripheral motor nerves during spinal surgery, which is designed to help predict and possibly prevent potential neurologic injury.
The NIM-Spine System allows surgeons to monitor the spinal cord and nerve roots throughout every stage of surgery to optimize the placement of spinal instrumentation and to reduce the risk of nerve-root irritation. To use the monitor, recording electrodes are placed in the muscles of associated nerve roots. If the nerve root becomes irritated, a signal will be generated and recorded by the monitor to alert the surgeon.
Intraoperative monitoring has been available for a number of years, but many neural monitors require highly trained technicians to operate the equipment and interpret the results. The NIM-Spine System provides the technical capabilities demanded by monitoring professionals, but can also be configured to allow surgeons to monitor the patient's nerve root and spinal cord function directly. The system provides intuitive audible and visual real-time feedback to aid in decision-making during spinal surgery.
"The NIM-Spine System represents a leveraging of Medtronic's extensive nerve monitoring expertise with our pioneering tissue-sparing spinal technology," said Michael DeMane, president of Medtronic's Spinal, SNT and ENT business. "This launch underscores the vital role that neural integrity monitoring can play in the rapidly expanding field of minimal access spine technology."
The NIM-Spine System offers two types of monitoring modalities, electromyographic (EMG) and motor evoked potential (MEP), another key benefit of the system. EMG provides the reporting on individual nerve roots, whereas MEP provides feedback on the spinal cord function. The combination of EMG and MEP monitoring significantly improves the flexibility of the system.
The NIM-Spine System can be used in spinal surgical procedures, and is designed specifically to meet the needs of spine surgeons. The NIM-Spine System is an extension of the Medtronic Xomed Ear, Nose and Throat (ENT) monitoring systems, which have been used successfully for more than 15 years. The NIM-Spine System received 510k clearance from the US Food and Drug Administration in June 2003, and is being released after extensive evaluation by surgeons with expertise in neural monitoring.