Despite modern anti-seizure medications, approximately one third of people with focal epilepsy do not achieve adequate seizure control. Existing alternatives — from additional medications to vagus nerve stimulation and resection — are not suitable or sufficiently effective for all patients. The result: persistent seizures, reduced quality of life, and a daily life marked by uncertainty. EASEE® offers a new therapeutic option.

Minimally invasive. Close to the focus.

EASEE® is not placed in the brain but subcutaneously on the skull — individually positioned directly above the epileptic focus. From there, EASEE® precisely modulates the activity of the epileptic network. The epicranial approach is significantly less invasive than conventional neurosurgical procedures or other systems — a decisive advantage for patients for whom an intracranial intervention was previously not an option.

Clinically proven. Measurably effective.

The efficacy of EASEE® is supported by study data: after 24 months, the data show a median seizure reduction of 68%, with a responder rate of 65.4%. In the final month of the 24-month observation period, 23% of patients were seizure-free. EASEE® demonstrated a well-tolerated safety profile — no serious therapy-related adverse events were observed. Robust evidence for a therapeutic option that can be considered earlier than expected.

MRI clean. Without compromise.

The EASEE® system is MRI conditional at 1.5 and 3 Tesla, including in close proximity to the implant. Diagnostically relevant brain structures remain clearly assessable and artefacts are minimised. Neurological diagnostics therefore remain possible after implantation — a decisive advantage in everyday clinical practice.

Reversible. Patient-specific.

The EASEE® therapy is individually adjustable and fully reversible. The system can be adapted, deactivated, or even completely removed as needed, without leaving permanent changes to the brain. The epicranial approach keeps the therapeutic decision open and flexible — an important consideration particularly in conditions with a variable course, such as focal epilepsy.

Placement of EASEE®

A thin, flexible electrode is implanted subgaleally. Using a tunneling device, the connecting cable is guided subcutaneously down to the chest area, where it is connected to the pulse generator placed under the skin. This requires two small incisions in total. 

Ultra-thin, implantable pseudo-Laplace electrode

The innovative electrode arrangement of the EASEE® lead enables focused stimulation of the brain — without touching it.

A so-called Laplace electrode makes it possible to generate fields and current flows perpendicular to the plane of the array. In the EASEE® system, the outer ring-shaped electrode is replaced by four individual electrodes in order to adapt the orientation of the resulting electric field to spatially varying resistances. This allows significant current flows to be achieved at the brain surface and in deeper structures — similar to more invasive procedures.

Implantable Pulse Generator (IPG)

The EASEE® Power IPG is designed for patient-specific therapy and precisely and safely controls two combinable stimulation patterns: HFS (high-frequency stimulation) to interrupt seizures and DLS (DC-like cathodal stimulation) for neuromodulation. Personalizable parameters and integrated safety mechanisms support flexible, evidence-based, and safe neurostimulation.

Therapy that adapts to the person

The configuration of the stimulation patterns has a decisive influence on therapeutic success. EASEE® makes it possible to adjust stimulation parameters non-invasively from outside — individually tailored to the person affected. In addition, if they experience an aura, patients can trigger targeted stimulation themselves via remote control, allowing them to actively participate in their therapy.

DC-like Mode of Action (DLS)

The DC-like cathodal stimulation (DLS) of the EASEE® system enables long-term inhibition at the epileptic focus. It reduces cortical excitability of the epileptic network through hyperpolarisation. Its goal: a long-term reduction in seizure frequency in drug-resistant focal epilepsy.

HFS Mode of Action

High-frequency stimulation enables the acute interruption of incoming epileptic seizures by immediately suppressing pathological neuronal activity. With EASEE®, you combine long-term neuromodulation with acute seizure interruption.

PCN Mode of Action

With Patient Controlled Neurostimulation (PCN), you enable your patients to trigger on-demand additional stimulation: they can initiate a burst themselves, for example during an aura. For you as the treating clinician, this means individualised therapy supplementation within a clearly defined neurostimulative framework.

Proven Efficacy over 2 Years

As a treating clinician, you need robust long-term results: after 24 months, 65.4% of patients achieved a ≥50% reduction in seizure frequency. Almost one in three patients achieved a seizure reduction of ≥90% after 24 months. In the final month of the 24-month observation period, 23% of patients were seizure-free. This high responder rate confirms the sustained efficacy of EASEE® in drug-resistant focal epilepsy.

EASEE® also demonstrated a well-tolerated safety profile — no serious therapy-related adverse events were observed.1

Sustained Seizure Reduction over Time

The study data demonstrate not only early effects, but continuous improvement over time: after 2 years, a median seizure reduction of 68% was achieved — indicative of long-term neuromodulation rather than short-term effects.1, 2

High Therapy Retention Reflects Tolerability and Acceptance

Four out of five patients continued EASEE® therapy through at least the 2-year follow-up — despite the necessary pulse generator replacement in the second year. 1

*EASEE® now has a battery life of at least 3 years.

More than just Seizure Control

Beyond reductions in seizure frequency, the study data show positive effects on quality of life, mood, and neurocognition. Neurocognitive performance improved significantly (EpiTrack®), while emotional stability was maintained throughout the study period.1

EASEE II – First-in-Human Study Launch

2019

Completed

EASEE II was a prospective, multicenter study in which adults with drug-resistant focal epilepsy received the newly developed EASEE® system. The study evaluated the safety, tolerability, and effectiveness of the stimulation.

PIMIDES I – Second Study Launch

2020

Completed

PIMIDES I was the second prospective, multicenter study in which adults with epilepsy were treated with the EASEE® system. In addition to continuous stimulation, patients were able to trigger an on-demand stimulation bolus whenever needed.

EASEE4YOU – Pivotal Study Launch for Adolescents

2023

Ongoing

The EASEE4YOU study is evaluating the safety and effectiveness of EASEE® in adolescents aged 12–17 years with epilepsy as a new treatment option for drug-resistant focal epilepsy. With the completion of patient enrollment in early 2026, an important milestone was reached on the path toward approval of EASEE® for children aged 12 years and older. Initial results are expected in 2027.

EASEE-LEE

2023

Ongoing

The international long-term registry study EASEE-LEE is monitoring the safety and effectiveness of EASEE® in patients with epilepsy for up to five years.

EASEE-PEARL – German Registry Study Launch

2024

Ongoing

The EASEE-PEARL registry study collects real-world data on the EASEE® system in Germany and follows people with epilepsy over a period of three years.

BRAIN-MEP – European Study on Treatment Response Prediction Launch

2024

Ongoing

This multicenter project led by the University Medical Center Freiburg aims to improve the prediction of treatment response to EASEE® by analyzing retrospective and prospective data using statistical methods and machine learning. 

EASEE4US – U.S. Pivotal Trial Launch

2026

In Preparation

The U.S. Food and Drug Administration (FDA) has approved the conduct of a randomized, double-blind pivotal trial involving approximately 200 people with epilepsy. The study is planned to begin in the second quarter of 2026.

Components:

Implanted electrode:
EASEE® Lead – REF: EALE02
UDI-DI 04260479770446

Implanted pulse generator:
EASEE® Power REF: EAPW01
UDI-DI 04260479770293

ParameterNotes
Item Name / IdentificationEASEE® Power (UDI-DI 04260479770293)
EASEE® Lead (UDI-DI 04260479770446)
Device ConfigurationShut down
Item ManufacturerPrecisis GmbH
Date this labelling was issuedMay 2022
Location of MRI safety informationopen PDF
Static Magnetic Field Strength1.5 T / 3 T
Type of NucleiHydrogen
Static Magnetic Field (B0) OrientationHorizontal
Scanner TypeCylindrical-bore
Maximum Spatial Field Gradient43 T/m (4310 gauss/cm)
Maximum Gradient Slew Rate per axis200 T/m/s
Encoding gradients (dB/dt) rms42 T/s
RF Excitation1.5T: Circularly Polarized (CP)
3T: Circularly Polarized (CP)
RF Transmit Coil TypeIntegrated Whole Body Transmit Coil
RF Receive Coil TypeAny receive coil may be used
Operating ModeNormal Operating Mode (including FPO:B Mode)
RF PowerB1+RMS ≤ 7 μT
or for scanners that do not report B1+rms:
Whole Body SAR ≤ 2 W/kg
Note: Under the RF scan conditions defined above, the EASEE® neurostimulator is expected to produce a maximum temperature rise of less than 2°C at 1.5T and at 3T after 15 minutes of continuous scanning.
Active Scan TimeScanning for 45 minutes max
Patient Characteristicsthe implantation is at least 5 weeks ago
uncompromised thermoregulation and under controlled conditions: a medical doctor or a dedicated trained person can respond instantly to heat induced physiological stress.
no previously implanted (active or abandoned) medical devices, leads, lead extenders, or lead adaptors
no broken lead or lead with intermittent electrical contact

Sources

1 Schulze-Bonhage et al., Epilepsia 2025

2 Schulze-Bonhage et al., Epilepsy & Behavior 2025

Discover more from PRECISIS

PRECISIS GmbH, based in Heidelberg, develops bioelectronic therapies that target the very source of neurological diseases – the brain itself. Learn more about our technology, our team, and the vision behind EASEE® for epilepsy.

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