Epilepsy Surgery or Neurostimulation?

Important Safety Information

You may be considering epilepsy surgery if you have drug-resistant focal epilepsy and anti-seizure medications alone are not working for you.

There are several types of epilepsy surgery for focal seizures, including resection and ablation (which either surgically removes or destroys a part of the brain with electrical energy). Another option can be neurostimulation therapy (the delivery of mild electrical pulses directly or indirectly to the brain) such as the RNS® System, vagus nerve stimulation (such as VNS Therapy*) or deep brain stimulation (DBS).

Implantation of a neurostimulation device does require a surgical procedure; prior to that, you will also need to have a comprehensive electroencephalography (EEG) or other diagnostic procedures. Neither the diagnostic nor the implantation procedures involve removing or destroying any brain tissue. You should speak with your physician about the procedures most appropriate for you.

*This trademark is owned by a third party

The RNS System vs. DBS vs. VNS?

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VNS Therapy, RNS System,
DBS vs Epilepsy Surgery

Which focal seizure treatment is right for me?

Epilepsy Surgery Neuromodulation Devices
Resective Surgery Laser Ablation1 VNS Therapy2 & DBS Therapy1 The RNS® System3
Targets the source of your seizures  
Preserves brain tissue    
Adjustable therapy    
Recognizes and responds to brain activity      
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Neuromodulation Devices
The RNS® System3
Targets the source of your seizures
Preserves brain tissue
Adjustable therapy
Recognizes and responds to brain activity
Neuromodulation Devices
VNS Therapy2 & DBS Therapy1
Targets the source of your seizures  
Preserves brain tissue
Adjustable therapy
Recognizes and responds to brain activity  
Epilepsy Surgery
Laser Ablation1
Targets the source of your seizures
Preserves brain tissue  
Adjustable therapy  
Recognizes and responds to brain activity  
Epilepsy Surgery
Resective Surgery
Targets the source of your seizures
Preserves brain tissue  
Adjustable therapy  
Recognizes and responds to brain activity  
  1. Medtronic Website, 2021.
  2. LivaNova Website, 2021.
  3. RNS System manuals at www.neuropace.com.

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What makes the RNS System so smart?

The RNS System is the only responsive device that can stop seizures before they start and also allow your doctor to see your seizure activity.

Monitors

It monitors brain activity continuously.

Recognizes & Responds

It is programmed to recognize a person’s unique seizure patterns, and automatically responds to prevent seizures before they start.

Records & Reports

It records and reports EEG data to help doctors personalize patient care.

Monitors

It monitors brain activity continuously.

Recognizes & Responds

It is programmed to recognize a person’s unique seizure patterns, and automatically responds to prevent seizures before they start.

Records & Reports

It records and reports EEG data to help doctors personalize patient care.

Proven seizure reduction

In a real world study, RNS System patients reported experiencing fewer seizures.1

Significant Seizure Reduction

graphic of chart with eighty two percent

Median seizure frequency reduction at ≥3 years

vertical line

More Seizure-free Days

one in five icon

~1 in 5 patients were seizure-free at their last check-up

  1. Razavi, et al. Epilepsia, 2020.

What to expect with the RNS System procedure

The RNS System involves a surgical procedure that is performed by a trained neurosurgeon. Prior to the procedure, your medical team conducts diagnostic testing to identify the location in your brain where your seizures start.

During the procedure, your surgeon positions the leads at the seizure source and places the neurostimulator in your skull. Once implanted, the device is hidden under your scalp—unnoticeable to you and others.

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How the RNS System Works

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FAQs

Who is a candidate for the RNS System?

The RNS System is for individuals aged 18 and older who have tried at least 2 anti-seizure medications but still suffer from frequent and disabling focal (partial onset) seizures that come from one or two areas of the brain. Talk with your doctor to find out if the RNS System is right for you.

Will I be able to stop taking my anti-seizure medications?

The RNS System is considered a complementary treatment to your medications. Any change in your medications would be determined by your doctor.

When should I consider the RNS System?

Studies have shown that if you have tried two anti-seizure medications without achieving seizure control, there is a less than 5% chance that your seizures will be controlled on another medication. If you have failed two medications and still suffer from seizures, it may be time to ask your doctor about other treatment options, including the RNS System.

Chen, Z., et al. JAMA Neurology, 2018.

Is the RNS System covered by insurance?

The RNS System is broadly covered by most private and government insurance.

Can I expect to be seizure free?

Although you should not expect seizure freedom from the RNS System, a subset of patients report experiencing seizure-free periods.

In 9-year clinical study:

  • 35% of patients achieved ≥ 90% seizure frequency reduction*
  • 28% of patients had at least one ≥ 6 month period with no seizures

*during last 6 months of follow up, at 9 years
Nair, et al. Neurology, 2020.

What are the side effects of the RNS System?

The primary side effects associated with the RNS System are those that are related to any surgical procedure, such as risk of infection or bleeding. However, the RNS System does not cause the chronic side effects associated with many anti-seizure medications such as dizziness, drowsiness, depression, or confusion. It also does not have the ongoing stimulation-related side effects that can be associated with vagus nerve stimulation, such as hoarseness, shortness of breath, sore throat, or coughing. Consult with your doctor about the full risks and benefits of the RNS System and see the RNS System Safety Information.

LivaNova VNS Therapy System Epilepsy Physician’s Manual, May 2020. Heck, et al., Epilepsia, 2014.

Will I feel the stimulation?

When your doctor programs the device to the correct settings for you, you should not feel or notice stimulation. On average, the total amount of stimulation delivered by the RNS System adds up to approximately three minutes per day.

Nair, et al. Neurology, 2020.

Does the stimulation effect wear off?

No. Experience over many years shows seizure reduction continues to improve over time.

Nair, et al. Neurology, 2020.

Does the procedure involve brain surgery?

When doctors talk about epilepsy surgery, or brain surgery, they are often describing the removal of a portion of the brain that is causing your seizures. Similar to traditional epilepsy surgery, the RNS System targets the part of your brain that is causing the seizures. However, unlike epilepsy surgery, the surgical procedure to place the RNS System does not involve removing any brain tissue.

Where is the RNS System available?

The RNS System is currently available at most Comprehensive Epilepsy Centers (CECs) throughout the United States. CECs are specialized epilepsy centers that have a team of experts who can provide a complete evaluation for epilepsy patients, along with extensive medical, interventional, and surgical treatment options.

Find a Comprehensive Epilepsy Center near you

How long will my RNS System battery last?

The estimated battery life of the RNS-320 Neurostimulator is nearly 11 years*. This means that on average you will likely be able to go over a decade after your procedure before needing a Neurostimulator replacement. Since battery life depends on your individualized settings, some people may have a shorter battery life, while others may have more than 11 years of battery life.

To find which RNS System model you currently have, please refer to your RNS System ID card, or call your doctor’s office. Consult the Patient Manual for more information.

*FDA-approved labeling reflects an estimated 10.8 years of battery life at medium settings.

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14%
    The RNS System is for individuals 18 and older who have focal epilepsy and have tried two or more medications without finding seizure control.
  • Based on your answers, your patient might benefit from the RNS System.

    Get your profile and a list of questions to ask your doctor.

  • Unfortunately it appears your patient is not an appropriate candidate for the RNS® System at this time.

  • The RNS® System is intended for patients who have undergone diagnostic testing that localized no more than 2 epileptogenic foci.

    If your patient has not undergone diagnostic testing, search here to find a comprehensive epilepsy center that can evaluate your patient, including determining if the RNS System is right for them.

  • If you are interested in learning more about the RNS® System, you can have an RNS® System professional contact you by filling out the form below:

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