Products and Procedures
Medtronic was named one of the “50 most innovative companies” by MIT Technology Review for our leadership in the development and introduction of deep brain stimulation (DBS) therapy. Since 1995, more than 100,000 patients worldwide have received Medtronic Deep Brain Stimulation Therapy for Parkinson's disease, essential tremor, and dystonia.* 1 Only Medtronic offers deep brain stimulation systems that have FDA-approved labeling 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
Neurostimulators
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Activa PC NeurostimulatorModel 37601 Indications: Parkinson's disease, essential tremor, dystonia |
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Activa RC NeurostimulatorModel 37612 Indications: Parkinson's disease, essential tremor |
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Activa SC NeurostimulatorModels 37602 and 37603 Indications: Parkinson's disease, essential tremor, dystonia |
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Discontinued Products
What does this mean?Kinetra NeurostimulatorModel 7428 |
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Soletra NeurostimulatorModel 7426 |
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Leads
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DBS LeadModel 3387 |
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DBS LeadModel 3389 |
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Extensions
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DBS ExtensionModel 37086 |
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DBS ExtensionModel 7483 |
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Accessories
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DBS Tunneling Tool KitModel 3755 |
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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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Discontinued Products
What does this mean?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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Deep Brain Stimulation Implant Procedure Overview
The deep brain stimulation (DBS) implant procedure involves implantation of 1 or 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 model 37022 can be used to assess the suitability of a Medtronic deep brain stimulation neurostimulator. For information on this product, 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.
Targeted Site
The targeted deep brain stimulation site varies by movement disorder:
For Parkinson's Disease and Dystonia*
Electrical stimulation is delivered to structures involved in the control of movement within the subthalamic nucleus (STN) and globus pallidus (GPi).
For Essential Tremor
Electrical stimulation is delivered to targeted cells in the left or right ventral intermediate nucleus (VIM) of the thalamus.
Placement of the System
The neurostimulator is placed in a pocket in the subclavicular area. 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.
Placement of the neurostimulator may be done on an inpatient or outpatient basis, and may or may not be done at the same time as the lead placement. Patients typically receive general anesthesia during this procedure.
- A small incision is made in the subclavicular area to create a pocket and the neurostimulator is placed 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
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 37086 must be implanted to accommodate the new connector block.
Procedure Videos
Medtronic offers the following procedure videos to qualified healthcare professionals. Please register or Log In to view these videos.
Deep Brain Stimulation Therapy: A Systematic, Accurate, and Predictable Approach
This series of videos explains the implantation of a DBS Therapy system. Detailed procedural instructions are provided in the product implant manual and must be reviewed before use.
Chapter 1: Introduction
(2:40, 17.6 MB)Explains that the video series will show two different techniques, in two different practices, for implanting the DBS system.
Chapter 2: Preoperative Imaging, Planning
(:54, 4.5 MB)Shows how imaging software is used to approximate placement of the lead in the target site.
Chapter 3: Preoperative Stereotactic Frame Placement
(2:51, 15.2 MB)Presents the process of using a stereotactic head frame for MRI imaging, path planning, and marking the planned location of burr holes.
Chapter 4: Preoperative Patient Preparation
(1:09, 6 MB)Describes preparation for the operative part of the procedure when a frame is used.
Chapter 5: Making Burr Holes
(1:44, 9.3 MB)Describes preparation for making the burr holes, then shows the procedure for making the holes.
Chapter 6: Preoperative Preparation, Nexframe® System
(1:10, 6.2 MB)Describes preparation for the operative part of the procedure when the Nexframe system is used, in contrast to the frame-based procedure described in Chapter 4.
Chapter 7: Placing Fiducials
(1:57, 10.3 MB)Explains when fiducials can be placed and describes the process of placing fiducials.
Chapter 8: Stereotactic Guidance with the Nexframe System
(2:35, 13.5 MB)Shows stereotactic guidance using the Nexframe system.
Chapter 9: Microelectrode Recordings
(2:00, 10.3 MB)Presents the process of making microelectrode recordings for localizing the precise physiological target for DBS placement.
Chapter 10: DBS Lead Placement
(2:01, 10.6 MB)Shows how a DBS lead is placed into the target location, then fixed into place.
Chapter 11: Comprehensive Physician Support
(1:34, 8.3 MB)Discusses the expert technical support for the procedure solution for deep brain stimulation systems from Medtronic.
Prescribing and Pre-implant Manuals
This guide provides precautions, patient selection, clinical study, and patient counseling information.
This addendum to the Medtronic DBS Therapy Information for Prescribers provides information that is specific to Parkinson’s disease and essential tremor.
This insert states the indications for Medtronic DBS Therapy for Parkinson's Disease and for Tremor and lists the system components.
This addendum to the Medtronic DBS Therapy Information for Prescribers provides information that is specific to dystonia.
This insert presents the indications for Medtronic DBS Therapy for dystonia.
This manual provides information on test stimulation, screening for patient eligibility, battery recharging frequency, and battery longevity.
Implant Manuals
This manual provides instructions for using the external neurostimulator model 37022, a temporary screening system used intraoperatively during lead placement or test stimulation.
This manual provides instructions for implanting the Activa® PC neurostimulator model 37601.
This manual provides instructions for implanting the Activa RC neurostimulator model 37612.
This manual provides instructions for implanting the Activa SC neurostimulator model 37602.
This manual provides instructions for implanting the Activa SC neurostimulator model 37603.
These are the instructions for using the Kinetra® neurostimulator model 7428.
This is the technical manual for the Soletra neurostimulator model 7426.
This manual provides instructions for using the lead kits models 3387S and 3389S for Medtronic deep brain stimulation for movement disorders.
This manual provides instructions for using the Medtronic deep brain stimulation extension model 7483.
This manual provides instructions for using the Medtronic deep brain stimulation extension model 37086, used with Activa SC model 37602.
This technical manual includes instructions for assembling the tunneling tool and tunneling the extension(s).
This manual provides instructions for using the Nexframe® stereotactic system, plus the Nexdrive® micropositioner and the Stimloc™ lead anchoring device.
Clinician Programming Manuals
This manual presents information for users of the N'Vision® clinician programmer model 8840, including an overview and description, as well as the use, maintenance, troubleshooting, and specifications of the programmer.
This guide provides programming instructions for the Activa RC, Activa PC, and Activa SC deep brain stimulation system, using the N'Vision clinician programmer and software application card model 8870 software version A. The guide supplements information provided in the neurostimulator technical manual.
This is the programming guide for software application card 8870 for the Kinetra, Soletra, and Itrel® II neurostimulators for deep brain stimulation.
Patient Manuals
This manual provides information for patients about their Medtronic deep brain stimulation system.
This booklet provides patients with DBS Therapy information specific to movement disorders.
This booklet provides patients with DBS Therapy information specific to dystonia.
This manual provides information for patients about the DBS patient programmer model 37642 that is used with the Activa family of neurostimulators.
This manual provides information for patients about the Access® therapy controller model 7436 that is used with the Kinetra neurostimulator.
This manual provides information for patients about the Access Review® therapy controller model 7438 that is used with the Soletra neurostimulator.
This pocket guide shows the basic steps for turning the neurostimulator on and off, and checking the battery status. This guide does not replace the product technical manuals.
This guide gives patients quick programming instructions for the Access Therapy controller model 7436.
This guide, intended for patients, describes the purpose of deep brain stimulation therapy for dystonia, including benefits, risks, and possible device complications.
MRI Guidelines
This manual provides comprehensive safety information and instructions for MRI head scans with patients implanted with DBS systems.
* Humanitarian Device: The effectiveness of this device for this use has not been demonstrated. Learn more about HDE.
References
- Data on file, Medtronic Inc.