Activa Therapy Implant Procedure

Step 1: Placement of the Medtronic DBS™ leads:

The patient is admitted to the hospital the morning of surgery or the evening before. The patient’s head is shaved, and a stereotactic head frame is attached to the patient’s skull under local anesthetic to keep the patient comfortable. The patient is then imaged with the frame on, and the surgeon localizes the target(s) using targeting software.

The patient is transferred to the operating room, where a nickel-sized (14 mm) burr hole is made in the patient’s skull for each lead to be implanted. A burr-hole ring is affixed to each opening.

The surgeon uses stereotactic frame guidance and techniques, such as CT imaging, MRI targeting, and microelectrode recording, to place the chronic stimulating electrode(s) in the targeted area. With the patient awake*, the neurosurgeon or neurologist performs test stimulation to confirm good therapeutic benefit (e.g., reduced rigidity and/or tremor) with minimal or no side effects.

When the surgeon has determined that the leads are optimally located, they are affixed to the burr hole rings, and the burr hole caps are inserted.

*Dystonia patients may not be awake during lead placement for Activa Dystonia Therapy.

Step 2: Placement of the neurostimulator (30 to 45 minutes per neurostimulator):

This step may be done either on an inpatient or outpatient basis, and may or may not be done at the same time as the lead placement.

Surgeons typically give patients general anesthesia during this procedure. The surgeon makes a small incision in the subclavicular area (or abdominal area for younger primary dystonia patients) to create a pocket and places the neurostimulator in the pocket. The lead is then connected to the extension, which is tunneled under the scalp, the skin of the neck, and down to the pocket. For bilateral applications, these steps are repeated for the other side.

This procedure may be done on either an inpatient or an outpatient basis, and may or may not be done at the same time as the lead placement.

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