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Home Therapies Neural Stimulation Brain Stimulation NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy
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NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy

Image Credit: NeuroPace

NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy.

On November 14, 2013, NeuroPace has now received FDA pre-market approval for the NeuroPace RNS System as a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs.

According to the press release:

The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9 percent reduction in seizure frequency in patients treated with responsive stimulation compared to a 17.3 percent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three month blinded period. The difference is statistically significant (p=0.012). For those subjects who reached two years post-implant, 55% of the subjects experienced a 50% or greater reduction in seizures.

Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.

External products include the programmer, a laptop computer with proprietary software that has a wand and telemetry interface enabling communication with an implanted RNS neurostimulator. Physicians use the programmer to non-invasively program the detection and stimulation parameters of an implanted device. Additional features of the programmer include the ability to view the patient’s brain electrical activity (electrocorticogram or ECoG) in real-time and the ability to upload the patient’s ECoGs that have been stored in the RNS neurostimulator.

(A) A schematic drawing and (B) a skull X-ray of the RNS® after implantation. The implantable device (1) records, processes and transmits electroencephalographic signals, in addition to generating the electrical stimuli. The implantable depth (2) and strip (3) electrodes monitor brain signals and deliver electrical stimulation to stop seizures. From: Technology Insight: neuroengineering and epilepsy—designing devices for seizure control, by William C Stacey and Brian Litt, Nature Clinical Practice Neurology (2008) 4, 190-201

 

Company website: www.neuropace.com

Click here for NeuroPace’s patents.

Click here for paper “Technology Insight: neuroengineering and epilepsy—designing devices for seizure control”, by William C Stacey and Brian Litt, Nature Clinical Practice Neurology (2008) 4, 190-201

NeuroPace Responsive Neurostimulator for the Treatment of Epilepsy

Image Credit: Medical College of Georgia

 

 
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