Medtronic has received approval from the US Food and Drug Administration (FDA) for BrainSense, its adaptive deep brain stimulation (aDBS) therapy for patients living with Parkinson’s disease.
The approval comes just one month after Medtronic received a CE mark in Europe for the system, which is designed to automatically adjust stimulation for Parkinson’s disease patients based on their unique brain activity to address symptoms such as involuntary shaking and balance issues.
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The medtech giant has also received FDA clearance for the BrainSense Electrode Identifier (EI). Also cleared in Europe, the EI provides a detailed view of the brain signals of Parkinson’s patients to help clinicians improve DBS programming and therapy optimisation.
Brett Wall, executive vice president and president of Medtronic’s neuroscience portfolio, said: “Medtronic is the only company in the world to offer an aDBS system that dynamically adjusts therapy in real time.
“This new era in Parkinson’s care represents more than a decade of intentional innovation – ushering in personalised neuromodulation at a scale that responds to a patient’s changing needs, equipping clinicians with unparalleled insights, and setting a new standard for DBS therapy.”
In 2024, the University of California, San Francisco (UCSF) undertook two studies that tested implants that used aDBS for Parkinson’s therapy, with the results published in Nature Communications and Nature Medicine in February and August 2024, respectively.
In light of the studies, GlobalData medical device analyst Cynthia Stinchcombe noted that the increasing integration of advanced technology in the management of neurological disorders fitted into the broader industry shift towards precision medicine, a matter further reflected in the FDA’s recent push for innovative solutions in Parkinson’s disease management.
The global neurological devices market is forecast to reach a valuation of $20.9bn by 2033, up from $12.5bn in 2023, according to a report by GlobalData.
Other companies developing aDBS systems for addressing Parkinson’s disease symptoms include Newronika. This month, the Italian company received an investigational device exemption (IDE) from the FDA for AlphaDBS, paving the way for the initiation of a pivotal trial of the system in the US. In addition, the company completed a €13.6m ($14.1m) Series B funding round to support the system’s further development.
