ABOUT THE THERAPY: EPILEPSY Deep Brain Stimulation

RENEWED HOPE FOR PATIENTS WITH MEDICALLY REFRACTORY EPILEPSY

Together, we can offer your patients who have not responded adequately to drug treatment a therapy clinically proven to significantly reduce the frequency of seizures, restoring their hope for improved quality of life. Additionally, Medtronic gives you the first safe* access to MRI anywhere on the body for diagnosing health conditions in patients with deep brain stimulation.

Bilateral anterior thalamic nucleus stimulation using the Medtronic DBS System for Epilepsy is indicated as adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications.  

The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness in patients who average 6 or more seizures per month over the three most recent months prior to implant of the DBS system (with no more than 30 days between seizures), and has not been evaluated in patients with less frequent seizures.

Medtronic Deep Brain Stimulation for Epilepsy is an effective and well-established therapy with proven results:

  • DBS significantly reduces the frequency of seizures in adults with medically refractory partial-onset epilepsy.1
  • DBS significantly reduces patients’ most severe seizures, complex partial seizures, and incidence of epilepsy-related injury.1
  • Long-term, patients who have tried VNS showed improvement in seizure frequency with DBS.1
  • Long-term, patients who have tried resective surgery showed improvement in seizure frequency with DBS.1
  • DBS improves long-term quality of life.1

HOW IT WORKS

Medtronic Deep Brain Stimulation for Epilepsy targets the anterior nucleus of the thalamus (ANT), part of a network in the brain involved in the generation and propagation of seizures. Leads implanted bilaterally in the ANT provide controlled electrical stimulation to modulate the network.

MEDTRONIC DBS SYSTEM

A Medtronic Deep Brain Stimulation system includes implanted leads, lead extensions, a neurostimulator, and programming devices.

Leads
Insulated leads deliver targeted electrical pulses to the anterior nucleus of the thalamus.

Lead Extensions
Used to connect the leads to the neurostimulator

Neurostimulator

  • A device similar to a cardiac pacemaker
  • Delivers controlled electrical stimulation at intervals programmed by the physician
  • Typically implanted under the skin in the upper chest

Clinician Programmer
Customized programming “individualized” for patients:

- Adjust stimulation parameters
- Create up to four distinct therapy groups
- Preconfigure certain stimulation options

InterceptTM Patient Programmer
Gives patients some control over therapy. With their programmer, patients can:

- Activate therapy by pressing “seizure button” if the patient senses a seizure coming2
- Log a seizure event by pressing "seizure button"
- Turn DBS therapy ON or OFF
- Check neurostimulator battery status
- Switch between 4 prescribed tharapeutic groups

ABOUT THE IMPLANT PROCEDURE

The DBS system is implanted using stereotactic targeting techniques. There are two parts to the surgery. Leads are placed bilaterally in the anterior nucleus of the thalamus using two small entry points, and lead extensions are tunneled behind the ear. The neurostimulator is implanted under the skin in the upper chest and is connected to the lead extensions.

The duration of the procedure and the specific steps involved can vary. Unlike Medtronic Deep Brain Stimulation for Parkinson’s disease and essential tremor where the patient is to remain awake during lead-implant surgery, the epilepsy procedure is performed with the patient under general anesthesia because intraoperative test stimulation is not required.

In situations when Medtronic Deep Brain Stimulation for Epilepsy is not tolerated, the system can be turned off or fully explanted. Unlike resective surgery, DBS therapy does not involve removal of brain tissue.


BENEFITS AND RISKS OF DBS THERAPY FOR EPILEPSY

EFFECTIVE AND WELL-ESTABLISHED

The safety and effectiveness of Medtronic Deep Brain Stimulation Therapy for Epilepsy is clinically meaningful and sustained through seven years.1

CONSISTENT AND SUSTAINED

DBS for Epilepsy was shown to reduce median seizure frequency, and these results improved over time. Our therapy benefits were consistent and sustained over time. After seven years, patients experienced a median 75% reduction in seizure frequency from baseline.1

FREEDOM FROM SEIZURES IS POSSIBLE

In Medtronic’s randomized controlled clinical trial called "SANTE" (Stimulation
of the Anterior Nucleus of the Thalamus in Epilepsy), the long-term safety and
effectiveness for DBS Therapy for Epilepsy was established with long term follow up through 7 years.

The 7 year data is available in the Medtronic DBS Therapy for Epilepsy Clinical
Summary found at manuals.medtronic.com.

CUSTOMIZED PROGRAMMING

Medtronic DBS Therapy for Epilepsy can be "individualized" for your patient. Using a clinician programmer you can adjust stimulation parameters to meet each patient’s individual needs. Programming optimization may take several months before patients begin to achieve significant therapy.

You can preconfigure certain stimulation options that your patient can try between appointments, involving them in their care and potentially reducing the need for repeat office visits to fine-tune programming. These programming options may help to increase patient acceptance and compliance.

FULL BODY MR CONDITIONAL*

Eligible patients with Medtronic DBS Therapy may have an MRI scan anywhere on the body under certain conditions. Refer to MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions and instructions for use.

Access MRI resources for clinicians

REVERSIBLE

Unlike resection surgery, DBS therapy does not involve removal of brain tissue and is reversible. Therapy may be turned off. In most cases, system components may be removed.

SAFETY PROFILE

The safety profile for the Medtronic DBS System for Epilepsy is stable, long-term, and has been well characterized with risks identified and quantified through a minimum of seven years of post-implant follow-up.

RISKS OF DBS THERAPY

Placing the DBS system requires brain surgery, which could have serious and even fatal complications including coma, bleeding inside the brain, stroke, seizures, and infection. Once implanted, the system may become infected, parts may wear through the skin, and the lead and/or extension connector may move. Medtronic DBS Therapy could stop suddenly because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen.

In patients receiving Medtronic DBS Therapy, depression, suicidal thoughts, and suicide have been reported.

This therapy is not for everyone. This therapy should not be used for patients who will be exposed to diathermy (deep heat treatment) or transcranial magnetic stimulation. Magnetic Resonance Imaging (MRI) should only be performed as described in the product labeling. The DBS system may interact with other medical devices and electromagnetic interference.

In addition to the risks and side effects related to DBS therapy, the following side effects can occur with DBS Therapy for Epilepsy: status epilepticus and changes in seizures (new seizure type or worsening seizures such as increased seizure frequency, duration, and/or severity).

Healthcare professionals must review the product technical manual prior to use for detailed disclosure. For information refer to Indications, Safety, and Warnings or call Medtronic at 800-328-0810.


*

Medtronic DBS systems are MR Conditional and safe in the MR environment as long as certain conditions are met.  If the conditions are not met, a significant risk is tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death.  Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions. 

 


1

Medtronic DBS Therapy for Epilepsy Clinical Summary, 2018.

2

This feature has not been clinically proven to stop seizures.