Aleva Neurotherapeutics's directSTIM Directional Deep Brain Stimulation (DBS) system has been successfully implanted in a patient during a study in Germany. DBS entails delivering mild electrical pulses to specific areas in the brain via an implanted lead connected to a battery-powered pulse generator placed in the patient’s upper chest area, Aleva reported in a news release. The study seeks to demonstrate improved outcomes for patients with Parkinson’s Disease and essential tremor through use of the directSTIMTM Directional DBS system.
Aleva’s DBS system employs a directional electrode technology designed to be more precise and efficient than currently available approaches, and it is the only DBS lead to have 12 directional electrodes, offering complete flexibility to surgeons, the company shared. Each directional electrode is rounded in shape, not rectangular, providing added safety and enhanced directional fields. These advantages are based on its proprietary microengineered leads using MEMS technology (microelectromechanical systems) developed and licensed from the Swiss Federal Institute of Technology, Lausanne (EPFL).
“The directSTIM system is simple and straightforward to use. We will be able to immediately determine the advantages of directional stimulation, and we look forward to completing the study with Aleva,” said Prof. Dr. Stephan Sobottka in the release. Dr. Sobottka performed the first implantation at the University Hospital of Dresden, Carl Gustav Carus, Clinic for Neurosurgery, Dresden, Germany.
“As one of the originators of Directional Deep Brain Stimulation, Aleva has done a substantial amount to study this modality and its benefit to patients. We expect to quantitatively determine its specific advantages within the Aleva study,” added Prof. Andres Lozano, Department of Neurosurgery, University of Toronto, and longtime Senior Medical Advisor to Aleva.
"Enrolling a first patient in our PMCF study is a significant milestone in Aleva's development. Our Deep Brain Stimulation System incorporates several technologies that will provide better outcomes for Parkinson’s patients," said Andr Mercanzini PhD, CEO of Aleva Neurotherapeutics.
Final study results are expected in the first half of 2022. Aleva is aiming to obtain IDE approval by the US FDA in Q4, 2021.