NeuroPace has announced that it has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate the NAUTILUS study—which will assess the company’s RNS system in patients with drug-resistant idiopathic generalised epilepsy (IGE).
IGE is the second most common type of epilepsy, after focal epilepsy, according to a NeuroPace press release. In the approximately one third of IGE patients who are not effectively treated with medications, this disorder is debilitating, has a substantial impact on day-to-day life, and carries risk for social and psychiatric disability, injury and premature death.
The NAUTILUS pivotal study will be the first in the USA to evaluate the use of brain-responsive neuromodulation for the treatment of IGE, the release adds. It is a prospective, single-blinded, multicentre, randomised study that is projected to start enrolling patients in 2022.
“We are pleased with FDA’s decision to grant IDE approval for the pivotal study, allowing us to evaluate the safety and effectiveness of the RNS system in patients who are living with drug-resistant idiopathic generalised epilepsy,” said Martha Morrell, chief medical officer of NeuroPace. “We look forward to working closely with the study investigators to evaluate a new treatment option that could potentially improve quality of life for these individuals in a meaningful way.”
The RNS system is the only FDA-approved brain-responsive neuromodulation system that delivers personalised, targeted treatment at the seizure source in patients with drug-resistant focal epilepsy. And, unlike other neuromodulation devices, the RNS system is a closed-loop technology that monitors and responds to a patient’s unique brain patterns to deliver therapy in real time—when and where it is needed—typically before clinical symptoms occur.
This IDE approval follows news from March 2021 that NeuroPace had received Breakthrough Device designation status from the FDA for the potential use of its RNS system to treat idiopathic generalised epilepsy.