Newronika announced it received CE mark approval for its AlphaDBS device for treating Parkinson’s disease.
AlphaDBS, the company’s next-generation, closed-loop deep brain stimulation (DBS) system treats other neurological diseases, too. It dynamically adjusts stimulation based on real-time brain signals.
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Newronika joins Medtronic in offering an adaptive DBS system after the medtech giant began its European rollout for the system after winning CE mark in January. Medtronic also won FDA approval for adaptive DBS for Parkinson’s a month later. Newronika plans to launch its system in select European markets this year. It also plans to later expand in the U.S. by initiating a pivotal trial, having received FDA investigational device exemption (IDE) last month.
AlphaDBS monitors the patient’s brain activity and automatically adjusts stimulation levels in response to real-time neurophysiological feedback. The personalized approach optimizes symptom control while reducing side effects. It also minimizes the need for frequent programming adjustments by neurologists.
Newronika said CE mark followed clinical data that demonstrated the safety and effectiveness of AlphaDBS. Trials showed more time without symptoms or side effects with adaptive DBS compared to the traditional DBS method. Patients also showed improved overall quality of life and greater preference for the adaptive mode.
“The CE Mark approval of AlphaDBS is a defining moment for Newronika and for the field of deep brain stimulation,” said Lorenzo Rossi, CTO and co-founder of Newronika. “This certification validates our vision of bringing truly adaptive neuromodulation to patients. We are excited to bring this technology to market and to set a new standard in the treatment of Parkinson’s disease.”
