Aleva’s first Deep Brain Stimulation System implanted

Deep brain stimulation (DBS) is approved worldwide for the treatment of Parkinson’s disease (PD), essential tremor, dystonia, obsessive-compulsive disorder (OCD), and epilepsy. The approach relies on the delivery of 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’s DBS system incorporates a directional electrode technology that is designed to be more precise and efficient than currently available approaches, as optimized stimulation has the potential to reduce side effects. Aleva is the only DBS company that provides 24 independent current sources and the only DBS lead to have 12 directional electrodes, providing the surgical team with complete flexibility. In stark comparison to competitors, each directional electrode is rounded in shape, not rectangular, providing added safety and enhanced directional fields. These advantages are based on its proprietary micro-engineered leads using MEMS technology (microelectromechanical systems) developed and licensed from the Swiss Federal Institute of Technology, Lausanne (EPFL).

Last week Aleva announced the successful implantation of a first patient with the directSTIM Directional Deep Brain Stimulation System. The procedure was performed by Prof. Dr. Stephan Sobottka at the University Hospital of Dresden, Carl Gustav Carus, Clinic for Neurosurgery, Dresden, Germany, and is part of a larger study being conducted in Germany that will include up to 60 patients. The revenue-generating study aims to demonstrate improved outcomes with the technology of Aleva´s directSTIM Directional Deep Brain Stimulation system in the EU for Parkinson’s Disease and Essential Tremor. Final results are expected in the first half of 2022.

In the USA, Aleva is aiming to obtain IDE approval by the US FDA in Q4, 2021. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data.