Lead Localization

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Using the System

Lead Localization Intended Use

The Lead Localization application suite is intended to be used post-operatively on a (laptop) computer in or outside an operating room to define the position of implanted leads in relation to patient imaging.

Indications for Use

Lead Localization indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g., with stereotactic image guided surgery or other devices for further processing and visualization.

Example procedures include but are not limited to:

Review of cranial surgical procedures, such as minimal-invasive stereotactic interventions, biopsy, planning and simulation of trajectories for stimulation and electrode recording.

Intended User

Lead Localization users are healthcare professionals educated for the planning and execution of DBS procedures. These are in general neurosurgeons or neurologists.

Patient Group

There are no demographic, regional or cultural limitations for patients. It is up to the medical professional to decide if the system shall be used to assist a certain treatment. Example procedures are listed in the indications for use.

Place of Use

The intended use environment is a (laptop) computer in a hospital (in office and operating room environment) or a doctor’s office. The common use environment is an office environment.

Careful Handling

Warning

Plausibility Review

Warning
Article No. 60917-70EN

Date of publication: 2018-07-25