RNS® System Epilepsy Post-Approval Study

Prior treatment

• 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).
• Subject is participating in a therapeutic investigational drug or device study
• Subject was treated with a VNS within the last three months (90 days)

Other

• This post-approval study has the following additional study related exclusion criteria:
• Subject is pregnant

• 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