Catheter and Electrode Placement Now FDA-cleared for Adult and Pediatric Patient Procedures
DUBLIN - Medtronic plc (NYSE: MDT) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of specific StealthStation® electromagnetic (EM) surgical navigation system instruments for pediatric 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 pediatric patients; shunt systems; connection to Ommaya reservoirs; hematoma drainage; external ventricular drainage catheters; neuroendoscope peel-away catheters; and for the placement of depth-electrodes[1].
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"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 EM 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."
StealthStation EM surgical navigation was developed by Medtronic in 2002. It is the most widely used EM navigation technology in the ENT and neurosurgery space with over 2,000 systems in use. With more than 70 patents issued and pending, Medtronic is the leader in cranial electromagnetic navigation.
About StealthStation Electromagnetic Surgical Navigation
Medtronic StealthStation electromagnetic surgical navigation system is a proprietary tracking technology that uses unique engineering to generate an electromagnetic field around a patient's targeted anatomy, triangulating the position of instruments relative to patient-tracking devices during surgical navigation procedures.
The StealthStation system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Procedures include general ventricular catheter placement; pediatric ventricular catheter placement; tumor resections; skull base procedures; craniotomies/craniectomies; and transsphenoidal procedures.
