RE: Consideration of Neurostimulation for Epilepsy, FDA Neurological Devices Panel Meeting,
February 22, 2013
Dear Dr. Krauthamer:
The American Association of Neurological Surgeons (AANS) and the Congress of Neurological
Surgeons (CNS) appreciate the opportunity to provide comments to the Food and Drug Administration
regarding neurostimulation for epilepsy patients, in advance of consideration of the NeuroPace
Responsive Neurostimulation System by the Neurological Devices Advisory Panel meeting on February
22, 2013.
Epilepsy affects over one percent of the US population (>2.5 million people). Yet over a third of these
individuals (> 700,000) will not find significant relief from medications. The likelihood that these people
will be helped by a traditional surgery is less than 10 percent, leaving a large portion of patients with
either medically or surgically untreatable epilepsy. These numbers have not changed for at least 10
years. Neurostimulation has been a therapy that has proven success in otherwise medically refractory
or surgically inappropriate patients with epilepsy. Neurostimulation represents a line of therapy that has
over 20 years of FDA approved indications, including success with refractory pain, Parkinson’s disease,
essential tremor, dystonia, urinary incontinence, gastric disorders and epilepsy. It is a line of therapy
that utilizes the safe nature of focused electrical stimulation to correct – or “modulate” – neural circuits
that are dysfunctional. There have been over 1,000,000 of such neuromodulatory devices implanted in
the past 25 years worldwide. It is an accepted and safe alternative to other forms of medical or surgical
treatments.
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