Image: The EASEE minimally invasive pacemaker has received CE certification (Photo courtesy of Precisis GmbH)
The treatment of epileptic patients always begins with medication. However, for decades there has unfortunately always been a large group of around 30% of all patients for whom pharmacological treatment is not sufficiently effective. These drug-refractory patients wait an average of 22 years before being offered other technical or surgical treatment options. Now, a new brain stimulator with minimized risk offers a new technological treatment option for drug-resistant focal epilepsies.
The EASEE (Epicranial Application of Stimulation Electrodes for Epilepsy) minimally invasive pacemaker from Precisis GmbH (Heidelberg, Germany) is an individualized brain stimulation system, which is anatomically precisely placed on the epileptic origin in the brain, but only surgically placed under the scalp. This means that the cranial bone is not opened and the brain itself remains intact. The fine EASEE electrodes are placed under the scalp and send bioelectrical impulses to the place in the brain where epileptic seizures originate.
The thin flat electrodes are not visible from the outside and guarantee unrestricted freedom of movement for the patient. Therapy pulses can be individually tailored to each patient, and optimizations can be made regularly throughout the duration of treatment; the patients do not feel the stimulations. The implant’s safety and effectiveness have been proven in two European multicenter studies, and EASEE has received CE certification based on data from both clinical studies. The CE mark certifies that EASEE meets specified safety and performance requirements. As a result, EASEE will be available to adult epilepsy patients with immediate effect.
“The main aim of the studies was to demonstrate the safety of the system. However, it was particularly interesting for the patients and for us to see the reduction in seizures and to see a continuous improvement in seizure control,” said Professor Schulze. -Bonhage, MD. , head of department of the epilepsy center at the neuro center of the university hospital of Fribourg, head of clinical studies on EASEE. “Data evaluation after six months showed a reduction in seizure frequency of at least 50% in 17 of 33 participants. After six months of stimulation, four patients were completely seizure free. The low-risk implantation procedure and extremely positive spectrum of side effects suggest that EASEE will be a future treatment option for drug-resistant focal epilepsies. »
Related links:
Precisis GmbH
