RNS® System 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.
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.
Current Patient FAQs
How does the RNS System work?
Similar to a pacemaker that monitors and responds to heart rhythms, the RNS System is the first and only medical device that can monitor and respond to brain activity. The RNS System constantly monitors your brainwaves, detects unusual activity that may lead to a seizure, and responds within milliseconds by sending brief pulses to disrupt this unusual activity.
Will I feel the stimulation?
Your doctor programs the device so that you do not feel or notice the stimulation. On average, the total amount of stimulation delivered by the RNS System adds up to less than six minutes per day.
Does the effect of the RNS System wear off?
No. Experience over many years shows seizure reduction continues to improve over time.
Will I be able to stop taking my antiseizure medications?
The RNS System is considered a complementary treatment to your medications. Any change in your medications would be determined by your doctor.
How often should I use my remote monitor?
NeuroPace recommends you transfer data from the neurostimulator to the remote monitor at least once a day, as well as after a seizure. You should transfer data from the remote monitor to a secure database at least once per week. It is important that you talk to your physician about how often they would like you to use your remote monitor.
How often does the battery have to be replaced?
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.
How and when do I use the RNS System magnet?
The RNS magnet is used to tell the neurostimulator to record brain activity when you are experiencing a seizure. The RNS System is programmed by your doctor to monitor record and respond to your unique brain activity on its own, but swiping the magnet works like a highlighter, pointing out an event for your doctor to easily identify when reviewing your data. Your doctor is then able to make adjustments to optimize your treatment as needed.
Can I get an MRI?
Individuals who have the model RNS-320 Neurostimulator are eligible for MRIs under certain conditions. People with the model RNS-300M Neurostimulator CANNOT receive an MRI.
I am going on a trip and will be traveling by plane, will I have a problem going through airport security with my device?
Airport scanners will not damage the system but could cause or temporarily disrupt stimulation. You may want to let TSA personnel know that you have an implanted medical device by showing them your Medical Implant Identification Card. You may also want to bypass a body scan and opt for a pat-down security inspection. You can find more detailed instructions in the “Traveling with the RNS System” section of your Patient Manual.
I still have more questions, who can I talk to?
Our NeuroPace Patient Education Team is here to answer your questions and help you get the information you need. To reach our patient education team, please call (888) 646.8483 or email connect@staging.np-mtl.com
Response Epilepsy Study FAQs
Why is this study being done?
The purpose of the RESPONSE Study is to demonstrate whether the NeuroPace RNS System is safe and effective (works well) as an additional treatment in patients implanted at ages 12 through 17 who have drug-resistant focal epilepsy
How long will I be in this study?
You will be in the RESPONSE Study for 2 years after you are implanted with the RNS System.
What are my responsibilities if I take part in this study?
If you take part in this study you will be asked to do the following:
- Enter information in an electronic diary every day.
- Attend all study visits (~3-4 times a year, in-person or telehealth) and complete all study activities.
- Tell the study team about any side effects, illnesses and injuries (including hospitalizations) you have while you are in the study.
- Use the NeuroPace Remote Monitor to send information to your doctor.
Nautilus Study FAQs
Why is this study being done?
The RNS System is already approved by the FDA to treat some types of focal epilepsy, but it has not been approved for other types of epilepsy. The purpose of the NAUTILUS Study is to see if the RNS System is safe and effective (works well) as an additional treatment in reducing the frequency of primary generalized seizures in individuals 12 years and older who have drug-resistant idiopathic generalized epilepsy.
How long will I be in this study?
You will be in the NAUTILUS Study for 2 years after you are implanted with the RNS System.
What are my responsibilities if I take part in this study?
If you are enrolled in the NAUTILUS Study, you will be asked to do the following:
- Enter your seizure information in an electronic diary every day.
- Attend all study visits (3-4 times per year) for 2 years and complete all study activities. The first year the study doctor will see you in-person for appointments, and in the second year, some of your visits may be done in-person, by telehealth or by telephone.
- Tell the study team about any side effects, illnesses and injuries (including hospitalizations) you have while you are in the study.
- Use the NeuroPace Remote Monitor as instructed to send information from your device to your doctor.
