RNS® System Pivotal Study

Inclusion Criteria for enrollment:

• Subject has disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries or significantly impair functional ability.
• Subject's seizures are distinct, stereotypical events that can be reliably counted.
• Subject failed treatment with a minimum of 2 anti-seizure medications.
• Subject has remained on the same antiepileptic medication(s) over the 3 most recent consecutive months (other than acute, intermittent use of benzodiazepines). Subjects on the ketogenic diet are permitted if the diet has been stable for the preceding 3 months.
• Subject reports having an average of 3 or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures per month over the 3 most recent consecutive months, with no month with less than 2 seizures.
• Subject is between the ages of 18 and 70 years.
• Subject has undergone diagnostic testing that has identified no more than 2 epileptogenic regions.
• Subject is male or a female of childbearing potential using a reliable method of contraception or is at least two years post-menopause.
• Subject or legal guardian is able to provide appropriate consent to participate.
• Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual.
• Subject is able to complete regular office and telephone appointments per the protocol requirements.
• Subject is willing to be implanted with the RNS® System as a treatment for his/her seizures.
• Subject is able to tolerate a neurosurgical procedure.
• Subject is considered a good candidate to be implanted with the RNS® System.

Note: A subject is still eligible to participate if antiepileptic medication(s) were temporarily discontinued for the purposes of diagnostic or medical procedures during the preceding 3 months.

Exclusion Criteria for enrollment:

• Subject has been diagnosed with psychogenic or non-epileptic seizures in the preceding year
• Subject has been diagnosed with primarily generalized seizures.
• Subject has experienced unprovoked status epilepticus in the preceding year.
• Subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
• Subject is taking chronic anticoagulants.
• Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not be excluded.
• Subject is pregnant or planning on becoming pregnant in the next 2 years.
• Subject is enrolled in a therapeutic investigational drug or device trial.
• Subject has an implanted Vagus Nerve Stimulator (VNS) or is unwilling to have the VNS explanted. (VNS therapy must have been discontinued for at least 3 months prior to enrollment.)
• Subject has had therapeutic surgery to treat epilepsy in the preceding 6 months.
• Subject has had a cranial neurosurgical procedure (including endovascular procedures) other than an epilepsy surgery involving the skull or brain in the previous month.
• Subject is implanted with an electronic medical device that delivers electrical energy to the head.
• Subject is an unsuitable candidate for neurosurgery.
• Subject requires repeat MRIs in which the head is exposed to the radio frequency field.
• Subject's epileptogenic region(s) is/are located caudal to the level of the thalamus.
• Implantation of the RNS® Neurostimulator and Lead(s) would present unacceptable risk.