Medtronic plc has announced that it has received clearance from the US Food and Drug Administration (FDA) for expanded indications of specific StealthStation electromagnetic surgical navigation system instruments for paediatric and adult cranial and ENT procedures.
The clearance for these StealthStation electromagnetic instruments enables additional neurosurgical applications that can benefit from flexible, tip-tracked instruments for both pinned and pin-less procedures. The navigated instruments can be used with compatible devices to aid in the placement of ventricular catheters for adult and paediatric patients; shunt systems; connection to Ommaya reservoirs; haematoma drainage; external ventricular drainage catheters; neuroendoscope peel-away catheters; and for the placement of depth-electrodes.
“This expanded indication of the StealthStation electromagnetic surgical navigation system instruments is very exciting for our business,” said Scott Hutton, vice president and general manager of Medtronic Neurosurgery, a business in Medtronic’s Surgical Technologies division. “It expands the scope of neurosurgical procedures that can benefit from the unique features of electromagnetic navigation—such as depth electrode placement for epilepsy seizure monitoring, and pin-less, MRI-conditional patient tracking during intraoperative MRI imaging. This is an achievement for the neurosurgical community, and represents our commitment toward advancing this innovative technology to benefit patients.”