Heidelberg, Germany-based bioelectronics company Precisis GmbH’s EASEE, a minimally invasive brain pacemaker, has received CE certification—making it available on the European market for adult epilepsy patients. The certification is based on the new standard of Medical Devices Regulation (MDR), which requires additional reports and extensive technical documentation on the producer's part compared to the previously applicable Medical Devices Directive (MDD).
The system’s acronym stands for Epicranial Application of Stimulation Electrodes for Epilepsy. Transmitting bioelectric pulses to the epileptic seizure point of origin in the brain, EASEE electrodes are implanted under the scalp in a process that has had its safety and effectiveness tested in two separate European multi-center studies. This process neither opens the cranial bone nor directly touches the brain.
Patients dealing with drug-refractory focal epilepsies will now be able to tap into a technological option for their therapy. "The treatment of patients with epilepsy always begins with medication,” said Professor Christian Elger, MD, Medical Director and Managing Partner of the Beta Neurologie Bonn – Center of Excellence for Epilepsy. “However, for decades there has unfortunately been a consistently 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 they are offered further technical or surgical treatment options. With this new, risk-minimized EASEE method, the treatment spectrum is expanded in the early phases of the disease."