Device Dossier

Universal Guide Tubes-Medtronic - Stereotactic surgery system, neurological

Device Dossier for Universal Guide Tubes-Medtronic - Stereotactic surgery system, neurological (Stereotactic surgery system, neurological, Class III,…

Intended purpose

The guide tubes are intended to be used for guiding electrodes in combination with the Elekta/ inomed MicroDrive during surgical interventions on the brain. The guide tubes are designed to stop in the specific distance to the target, to guide electrodes used for micro electrode recording (MER) and deep brain stimulation (DBS).

Functional description

The device incorporates three components: inner guide tube for electrode, outer guide tube for DBS lead and a mandrin. During insertion of the device all components are combined. The Elekta/ inomed MicroDrive is used to position the device. After insertion the mandrin is removed and the electrode is inserted through the inner guide tube. After a successful MER the electrode and inner guide tube are removed. The DBS lead is inserted with the outer guide tube.

TGA Public Summary