Medtronic’s adaptive DBS system receives CE mark in Europe
BrainSense technology helps personalize DBS therapy for each patient
Medtronic’s BrainSense adaptive deep brain stimulation (aDBS) system and electrode identifier have received CE Mark approval in the European Union (EU) and the U.K. for the management of Parkinson’s disease.
CE Mark approval indicates that the European Commission, the EU’s regulatory body, considered Medtronic’s system to meet pre-established safety, health, and environmental protection requirements. The designation is needed for products to be marketed in the EU, meaning that all companies around the world must follow the same rules.
BrainSense aDBS, electrode identifier available in Europe early this year
According to the company, the BrainSense aDBS and electrode identifier will be available in Europe early this year. Medtronic has also applied for FDA approval to market the system in the U.S.
“BrainSense technology is at the center of personalizing DBS therapy,” Paolo Di Vincenzo, president of the neuromodulation business at Medtronic, said in a company press release. “From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customize care for people with Parkinson’s.”
Parkinson’s disease is caused by the progressive dysfunction and death of dopaminergic neurons, the nerve cells responsible for producing dopamine, a chemical messenger involved in motor control.
DBS is a surgical treatment for Parkinson’s motor symptoms in those with advanced disease and in whom medication failed to control the symptoms. It involves implanting fine wires attached to electrodes connected to a small pacemaker-like device placed under the skin, to deliver electrical signals into target regions of the brain.
Unlike conventional DBS, which delivers constant stimulation regardless of symptom severity, adaptive DBS automatically adjusts the stimulation according to a patient’s brain activity.
“Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson’s,” said Martijn Beudel, MD, PhD, neurologist and professor at Amsterdam University Medical Center. “By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation that can be adapted to an individual’s unique needs.”
Medtronic’s Percept PC DBS neurostimulator with BrainSense technology records and analyses brain signals, which can be done while the patient is receiving therapeutic stimulation, both inside and outside the clinic.
Calibrates stimulation based on patient’s own brain signals
Moreover, the BrainSense Electrode Identifier can improve DBS programming by providing a detailed view of each patient’s brain signals and guiding clinicians to the precise location with the strongest signal in less time than conventional DBS.
“BrainSense Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalization unmatched in the field,” said Domenico De Paolis, vice president of neuromodulation international at Medtronic. “Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection.”
This enables brain stimulation to be adjusted to each patient’s pattern of neurological activity and provides clinicians with data on the impact of treatment decisions on the patient’s brain.
The device’s safety and efficacy, compared with conventional DBS, are being assessed in the ADAPT-PD trial (NCT04547712) in 85 adults with Parkinson’s disease. Results have shown that nearly all patients had symptom-related brain signals strong enough to induce aDBS, an effect that was independent of disease severity and electrode location in the brain.
About the Author
