Epiminder has reported the outcomes from the landmark UMPIRE (sub-scalp monitoring epileptic seizures) trial evaluating Minder, an implantable continuous electroencephalogram (EEG) monitoring system (iCEM).
The platform has been validated for its safety and efficacy in capturing high-quality EEG data over extended durations.
The trial, which took place across hospitals in Australia, has shown that the Minder system’s performance is comparable to the current standard of care scalp-based EEG monitors.
Minder has been recognised as a breakthrough device and recently authorised by the US Food and Drug Administration (FDA) through the de novo classification.
Key findings from the trial include the safety of the Minder system, without any serious adverse events related to the device or procedure.
The EEG signal clarity was found to be on par with the standard 10-20 scalp-based recordings.
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By GlobalDataClinically relevant outcomes were also observed in 88% of subjects with drug-resistant epilepsy, including those with frequent unreported seizures.
Minder’s bilateral recording feature demonstrated clinically significant observations that were not detectable with unilateral recordings in 23% of the subjects.
Epiminder’s chief medical officer and founder Mark Cook said: “The UMPIRE results exceeded our expectations, proving that continuous EEG monitoring over years, not just days, is not only possible but transformative for epilepsy management.鈥�
According to the company, this minimally invasive device is tailored for continuous monitoring of the brain’s electrographic activity.
It enables individuals to be monitored while they engage in their daily activities, providing data for understanding epilepsy and effective treatment alternatives.
Implanted under the scalp, the EEG recording and transmitting device is prescribed for use in those aged 18-75 years with drug-resistant epilepsy who cannot use or are not indicated or tolerant of more conservative monitoring tools.
It assists physicians in remotely assessing and monitoring patients’ conditions, with EEG data available for healthcare providers at various locations from where the data is gathered.
