Products and Procedures
Medtronic is the only company in the world that offers an approved deep brain stimulation (DBS) therapy for psychiatric disorders. Our Reclaim® DBS Therapy for obsessive-compulsive disorder received Humanitarian Device Exemption (HDE) approval in 2009. It is also FDA-approved for MRI head scans under specific conditions of use.
Our deep brain stimulation systems include the following components:
Procedural content for our deep brain stimulation system includes:
Products for Deep Brain Stimulation for Psychiatric Disorders
Neurostimulators
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Activa PC NeurostimulatorModel 37601 |
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Activa SC NeurostimulatorModels 37602 and 37603 |
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Kinetra NeurostimulatorModel 7428 |
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Soletra NeurostimulatorModel 7426 |
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Leads
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DBS LeadModel 3391 |
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Extensions
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DBS ExtensionModel 37085 |
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DBS ExtensionModel 7482 |
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Programmers
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N'Vision Clinician ProgrammerModel 8840 |
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DBS Patient ProgrammerModel 37642 |
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Access Therapy ControllerModel 7436 |
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Access Review Therapy ControllerModel 7438 |
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Procedure Solutions
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Procedure Solutionsfor Deep Brain Stimulation |
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Procedure Overview
The deep brain stimulation (DBS) implant procedure involves implantation of 2 leads, each with 4 electrodes, in the brain. Subcutaneous extensions connect the leads to a neurostimulator implanted near the clavicle. The electrical stimulation can be non-invasively adjusted to meet each patient's needs.
Implant Procedure
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 target(s) are localized using targeting software. For lead placement, a nickel-sized (14 mm) burr hole is then made in the patient's skull, and a burr-hole ring is affixed to each opening.
Prior to lead placement, microelectrode recording (MER) may be used to provide an additional level of target verification. Stereotactic frame guidance and techniques are then used to place the lead to the targeted area.
With the patient awake, a test stimulation is performed to confirm good therapeutic benefit with minimal or no side effects. When settings are found during the test stimulation to provide the maximum symptom suppression available to the patient, the implantable neurostimulator that can most closely approximates those parameters can be identified. It's important to note that not all neurostimulators have identical capabilities. For example, some neurostimulators will accommodate two leads, while others will not.
External neurostimulator models 37022 and 3625 can be used to assess the suitability of a Medtronic deep brain stimulation neurostimulator. For information on these products, see the DBS Product Ordering Guide.
Once lead placement is confirmed, the lead is secured by closing the burr-hole cover or Stimloc™ protective cap.
Post-surgery Follow-up
A deep brain stimulation patient typically is discharged the day following the placement of the leads. If the neurostimulator hasn't been placed along with the leads, the neurostimulator is usually implanted on an outpatient basis. In this case, the patient is discharged the same day.
Two to 4 weeks after surgery, a patient can go in for the first office visit to have the neurostimulator turned on and programmed, as determined by the clinician.
The patient will typically return to his or her clinician frequently in the first few months following surgery to optimize stimulation and titrate medications. Patients then resume a normal schedule of visits with their managing physician to monitor the status of their disease and adjust stimulation as necessary.
Replacing the Neurostimulator
Battery longevity is dependent on neurostimulator settings and usage. Replacement of the neurostimulator is typically done on an outpatient basis. No intracranial procedure is typically necessary.
If a physician is implanting an Activa® PC or Activa SC to replace a previous- generation deep brain stimulator (Kinetra® or Soletra®), then the lead extension model 37085 must be implanted to accommodate the new connector block.
Humanitarian Device: The effectiveness of this device for this use has not been demonstrated. Learn more about HDE.