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external Responsive Neurostimulator System · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| external Responsive Neurostimulator (eRNS) System | DEVICE | - |
Inclusion Criteria: * Subject is undergoing evaluation for epilepsy surgery in a manner consistent with the Surgery for Epilepsy, NIH Consensus Statement, 1990 Mar 19-21; 8(2); 1-20. * Subject is implanted with intracranial electrodes. * Subject is under constant medical supervision while implanted...
The external Responsive Neurostimulator System is an investigational medical device being studied for use in epilepsy. It is designed to detect and respond to epileptiform activity in patients with the condition. The system is currently in clinical development and has not been approved by the FDA.
The external Responsive Neurostimulator System is being developed by Neuropace, Inc., a company traded under the ticker symbol NPCE. Neuropace is conducting clinical research to evaluate the device's safety and effectiveness in patients with epilepsy.
The external Responsive Neurostimulator System is in Phase 2 clinical development. It is an investigational device, meaning it has not yet received regulatory approval. One Phase 2 study has been completed, and the device remains under evaluation for the treatment of epilepsy.
The external Responsive Neurostimulator System has been studied in one completed clinical trial, identified as NCT00158067. This Phase 2 study, titled 'Study of an External Responsive Neurostimulator System on Epileptiform Activity,' enrolled 150 participants with epilepsy in the United States.
The external Responsive Neurostimulator System is not FDA approved. It is an investigational device currently in Phase 2 clinical development for epilepsy. A completed clinical trial has evaluated its effects on epileptiform activity, but the device has not yet received marketing authorization.