What is RNS NeuroPace?
The RNS® System is the only FDA-approved epilepsy device that delivers personalized treatment by responding to abnormal brain activity and provides EEG data that can help improve patient care.
Is NeuroPace FDA-approved?
9, 2020 – NeuroPace, Inc., a Silicon Valley-based medical technology company, today announced that its RNS® System has received U.S. Food and Drug Administration (FDA) approval of MRI labeling for the RNS System, expanding treatment options for the approximately one million patients in the United States living with …
What does RNS system stand for?
Responsive neurostimulation device or RNS system is a neurostimulation system designed to prevent epileptic seizures. The RNS device is implanted while connected to leads that are placed in up to two areas where seizures begin.
How long is RNS surgery?
Surgery to implant the RNS system is performed under general anesthesia and typically takes between 2-4 hours. Many patients are able to go home the next day, and others can expect a 1-3 day hospital stay.
How is the RNS system implanted?
With RNS, surgeons implant a small battery-powered device called a neurostimulator in the patient’s skull. The neurostimulator is connected to thin wires, called leads, which the surgeon places in the area or areas of the brain where the patient’s seizures originate.
What is the difference between DBS and RNS?
Whereas RNS is indicated for epileptic foci within one or two regions, DBS can be considered a useful method of neuromodulation in patients whose epilepsy is more widely distributed. Similar to RNS, DBS requires placement of electrodes within the brain.
Is RNS FDA approved?
today announced that the U.S. Food and Drug Administration has granted premarket approval for the NeuroPace® RNS® System, a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs.
How does Responsive Neurostimulation work?
Responsive neurostimulation (RNS) is a type of surgery. During the surgery, a small device called a neurostimulator is placed in the skull. It can help to stop epileptic seizures by sending electrical impulses to the part of the brain where the seizure is starting. It works similarly to a pacemaker in the heart.
Is RNS surgery painful?
Most patients experience headaches and/or incisional discomfort during the first few weeks after surgery. The headaches and incisional discomfort will gradually become less frequent and less intense over the next few weeks.
How effective is RNS?
So far, these effects appear to improve over time in many people. 230 patients with the RNS® System were followed over time in a controlled trial. The average decrease in seizures was 44% after 1 year, 53% at 2 years, and up to 66% after 3 to 6 years of using RNS.
Does insurance cover RNS?
The RNS System is broadly covered by private and government insurance.
What are the side effects of deep brain stimulation?
Side effects associated with deep brain stimulation may include:
- Difficulty concentrating.
- Hardware complications, such as an eroded lead wire.
- Temporary pain and swelling at the implantation site.