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FDA Approves RNS, Implantable Neurostimulator for Epilepsy

FDA Approves RNS, Implantable Neurostimulator for Epilepsy

RNS-ImageThe US Food and Drug Administration (FDA) today approved an implantable neurostimulator to reduce the frequency of seizures in patients with epilepsy whose condition is not successfully managed with medication.

The device, called the RNS System (Neuropace, Inc), detects abnormal electrical activity and delivers a remedial dose of electricity before the patient experiences seizures. It contrasts with neurostimulators for other conditions that provide continuous or scheduled stimulation.

The RNS System is implanted inside the skull under the scalp. Its 1 or 2 electrodes are situated near the patient’s seizure focus or foci in the brain.

The FDA based its decision on a clinical trial involving 191 patients with drug-resistant epilepsy who received the implanted device. However, the device was turned on in only half the patients. After 3 months, patients with activated neurostimulators experienced almost a median 34% reduction in the average number of seizures per month. For patients with unactivated devices, the median reduction was 19%. Twenty-nine percent of patients with activated devices had at least a 50% reduction in the overall number of seizures, compared with 27% with turned-off devices.

In February, a 13-member FDA advisory panel recommended approval of the RNS System. The majority of panelists found that the device beneficial, and that the benefits outweighed the risks. There was unanimous agreement that the RNS System was safe.

Implant site infection and premature battery depletion were the most common adverse events reported during the clinical trials.

The FDA cautioned that patients with the RNS System must avoid MRI procedures, diathermy procedures, electroconvulsive therapy, and transcranial magnetic stimulation.

“The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off,” the agency said in a news release.

More information about today’s approval is available on the FDA Web site.

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5 Comments

  1. Thank u for the info!!! My Epileptologist !!!!!!!! BL worked on this for years!!!!

    Reply
  2. Isn’t it basically like the V.N.S…I have had that two years.

    Reply
  3. Yes but this specific implant from they way they talk they can put the 1-2 electrodes at the exact location where siezers r coming from so they couldnt use the rns in just anybody bc sum ppl like me thier siezers rnt in just 1 area

    Reply
  4. Here’s my thought: if you know where the seizure focus is (which clearly the RNS needs), why not consider surgery rather than add an implant? Just my opinion…

    I was unsuccessful with medications for over 28 years, but after having a resection earlier this year am now almost 8 months seizure-free!

    https://www.facebook.com/EnduringEpilepsy
    http://www.enduringepilepsy.com

    Reply
    • Most people like me would rather go through all their options first before having epilepsy surgery. To be honest epilepsy surgery scares the crap out of me. Risks of dying which I’ve had several friends dye from the surgery. Risks of not ever being yourself again. Depending on where your seizures are located and were they have to cut it could change your personality, memory, etc. I was born with epilepsy and medicine has not worked for 26 years. I’ve taken almost every medicine there is except one. Going to get my vns battery replaced for the second time. So in my opinion everyone doesn’t need to have epilepsy surgery forced on them. Let them go through their options. Talk through it with their neurologist and decide for yourself. I know a lot of people won’t agree with me but I’m fine with that. But if they want to try this out first or even the vns or even both before ever considering epilepsy surgery that’s their choice. Doesn’t mean that it’s dumb on their behalf.

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