RNS® System Epilepsy PAS
RNS® System Epilepsy PAS
The purpose of the study is to follow patients with partial onset seizures prospectively over
 5 years in the real-world environment to gather data on the long-term safety and
 effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists,
 and neurosurgeons trained on the RNS System.
NeuroPace, Inc. is sponsoring a post-approval study (PAS) of the RNS System device. The RNS
 System is the first FDA-approved closed loop responsive neurostimulator designed to reduce
 the frequency of seizures in individuals with partial onset seizures.

 The RNS System Epilepsy PAS is a 5 year, non-randomized, open-label, multi-center prospective
 observational study. Data regarding safety and efficacy are collected at enrollment and
 periodically throughout the 5-year study.

 The study is designed to assess the long-term safety and effectiveness of the RNS System as
 an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or
 older with partial onset seizures who have undergone diagnostic testing that localized no
 more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and
 currently have frequent and disabling seizures (motor partial seizures, complex partial
 seizures and/or secondarily generalized seizures).

 Data from the RNS System Epilepsy PAS will be used to calculate long-term SAE rates, median
 percent change in seizure frequency (from pre-implant retrospective data), as well as other
 safety and effectiveness endpoints.
Inclusion Criteria:

 A clinical decision to treat the patient with the RNS System in accordance with its
 approved indication for use has been made prior to enrollment in the study. For approved
 indication for use and contraindications, refer to current physician labeling and
 instructions for use (manuals) for the RNS System available at the NeuroPace website
 (www.neuropace.com).

 This post-approval study also has the following additional study related inclusion
 criteria:

 -  Subject or legal guardian is able to provide appropriate consent to participate

 -  Subject is able to maintain a seizure diary alone or with the assistance of a
 competent individual

 -  Subject is able to attend clinic appointments in accordance with the study schedule

 Exclusion Criteria:

 Per clinician assessment, treatment with the RNS System is contraindicated based on current
 RNS System labeling. For approved indication for use and contraindications, refer to
 current physician labeling and instructions for use (manuals) for the RNS System available
 at the NeuroPace website (www.neuropace.com).

 This post-approval study has the following additional study related exclusion criteria:

 -  Subject is participating in a therapeutic investigational drug or device study

 -  Subject was treated with a VNS within the last three months (90 days)

 -  Subject is pregnant