Product information

During the procedure to implant an Activa® System, a lead with four 1.5mm electrodes is surgically implanted in the brain and connected by an extension that lies subcutaneously to a neurostimulator implanted near the clavicle. The electrical stimulation can be noninvasively adjusted to meet each patient's needs.

Implantable Components
Neurostimulator The KinetraT neurostimulator is a totally implantable, non-invasively programmable, dual-channel neurostimulator. Only one neurostimulator is required for bilateral therapy, reducing surgical time and patient trauma. Kinetra has unparalleled battery capacity and can be used for both bilateral and unilateral stimulation. If used unilaterally a second lead can be added at a later date. Kinetra has unparalleled battery capacity .Activa therapy with Kinetra can be used for both bilateral and unilateral stimulation; if used unilaterally a second lead can be added at a later date.
	Quadripolar DBST Lead:Each lead consists of four thin, insulated, coiled wires and has four 1.5 mm electrodes at the end. The lead is implanted in the subthalamic nucleus (STN) or the internal globus pallidus (GPi) for Parkinson's disease, or in the ventral intermediate nucleus (VIM) for tremor of either Parkinson's or essential tremor origin. The lead delivers stimulation using either one electrode or a combination of electrodes.
Low profile extension An insulated wire that is passed subcutaneously along the head, neck, and shoulder to connect the lead to the implanted neurostimulator.

Patient-Operated Components

AccessT Therapy Controller The Access Therapy patient controller enables patients to adjust their therapy maximisingeffectiveness within physician set limits Physician control - adjustment parameters are set and locked by the physician Empowerment - designed to give patients more control over disease management andreduce dependence on the medical community Informative - indicator light allows for easy monitoring of the neurostimulator battery for peace of mind.

Physician Systems Components
	The Neurological Test Stimulator The clinician uses the Test Stimulator intraoperatively after the leads are placed to test patient response to Activa Therapy before the entire system is implanted.
Physician Programmer The N'VisionT programmer is the physician key to Activa therapy, enabling trouble-free remote programming of the KinetraT neurostimulators. It is a completely portable, lightweight, hand-held device that can be used anywhere, any time. With touch-screen programming and the capability to print to a standard desktop printer or to its own portable printer, the N'Vision programmer is an essential clinical accessory for any physician who demands the very highest standards of patient care.

Implanting the Activa® System
The Activa System is implanted by a functional stereotactic neurosurgeon, using a stereotactic head frame and imaging techniques such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning to map the brain and localize the target within the brain. The lead is inserted through a 14mm burr hole in the skull and implanted in the targeted site within the brain.

Before the lead implant procedure, the patient's scalp is anesthetized. The burr hole is made and a test stimulation electrode is passed to the target in the brain. The patient remains awake and alert so the neurosurgeon and a movement disorder neurologist can test the stimulation to maximize symptom suppression and minimize side effects before placement of the chronic stimulation lead.

Once the chronic stimulation lead is properly placed, the patient is put under general anesthesia. Then, an extension is passed under the skin of the scalp, neck, and shoulder to connect the lead to the neurostimulator. Finally, a small incision is made near the clavicle, and the neurostimulator is implanted subcutaneously.