Medtronics’ BrainSense Adaptive DBS and Electrode Identifier Gain CE Mark Approval for Parkinson Disease

Paolo Di Vincenzo

According to a new announcement from Medtronic, the company has gained CE Mark approval in the European Union and the United Kingdom for its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI), 2 technologies that will help contribute more efficient, patient-specific care for individuals with Parkinson disease (PD).¹

The approval was granted after the regulatory bodies felt as though the technologies met the standards required by the EU Medical Device Regulation (MDR). Medtronic also noted that it recently filed for US FDA approval of aDBS and will await word from the agency. Similar to its EU submission, the device’s supportive evidence will stem from the ADAPT-PD trial, a recently published real-world prospective study (NCT04547712) of patients with PD.²

Both part of Medtronic’s BrainSense platform, there are a few key differences in the function and purpose of each device. aDBS dynamically adjusted DBS in real-time based on patient-specific brain activity, enhancing therapy personalization whereas EI optimizes initial DBS programming by precisely identifying the strongest signal location using local field potentials and alpha-beta activity, saving time compared with traditional methods.

"BrainSense™ technology† is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform," Paolo Di Vincenzo, president of the Neuromodulation business, at Medtronic, said in a statement.¹ "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, and we're just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy."

The 2 devices have different purposes as well. aDBS focuses on continuously adapting stimulation to address PD motor symptoms and improve daily disease management whereas EI aims to streamline and improve the efficiency of contact selection during DBS setup for precise therapy delivery. Furthermore, EI elevates precision in electrode placement, enabling quicker and more effective DBS programming.

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"The CE Mark approval of BrainSenseTM Adaptive DBS is a critical advancement in how we treat Parkinson disease,” Alan Whone, PhD, a professor of movement disorders neurology at the University of Bristol, said in statement.¹ "Its potential to address certain challenging motor symptoms and improve day-to-day disease management offers new hope for patients and their families, broadening the transformative impact of deep brain stimulation."

The potential of Medtronic’s aDBS in clinical practice was highlighted in the pivotal ADAPT-PD trial, a global, prospective, single-blind randomized crossover study. Published in npj Parkinson’s Disease, the study featured 68 patients with either subthalamic nucleus or globus pallidus internus DBS connected to a Medtronic’s Percept PC neurostimulator. Trial participants were monitored over 4 phases spanning more than a year, including baseline examination, initial aDBS set up and adjustment, evaluation, and long-term follow-up.²

During the enrollment and screening procedures, a local field potential (LFP) (8-30 Hz; ≥1.2 µVp) control signal was identified by clinicians in 84.8% of patients on medication (65% bilateral signal) and in 92% of patients off medication (78% bilateral signal). Consequently, investigators concluded that detection of an LFP signal may be sufficient for aDBS programming in the large majority of patients without necessitating medication withdrawal. One limitation to the reported LFP detection rate was that some study physicians pre-screening participants for LFP peak presence, leading to a potentially inflated LFP detection rate; however, the estimate of peak detection (84%) was closely aligned with existing literature suggesting a detection rate of 78-95% in the off-medication state.

"BrainSense™ Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalization unmatched in the field," Domenico De Paolis, vice president of Neuromodulation International at Medtronic, said in a statement.¹ “Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world."

In August 2024, the FDA granted approval to Medtronic’s DBS technology to be used while a patient is under general anesthesia, or asleep, in the context of PD or essential tremor. This ultimately paved the way for greater treatment opportunities to a significant portion of potential candidates for surgery. A 2021 phase 2 trial evaluated asleep DBS using Medtronic’s O-arm imaging guidance and found motor outcomes comparable to standard awake DBS. Six months post-surgery, motor improvement rates on the UPDRS Part III were 52.3% in the asleep group and 47.0% in the awake group. Adverse event rates were similar, occurring in 33% of awake and 40% of asleep DBS patients.³

REFERENCES
1. Medtronic achieves CE Mark approval for BrainSense™ Adaptive deep brain stimulation and Electrode Identifier, a groundbreaking advance in personalized, sensing-enabled care for people with Parkinson's through innovative brain-computer interface technology. News release. Medtronic. January 13, 2025. Accessed January 13, 2025. https://news.medtronic.com/2025-01-13-Medtronic-achieves-CE-Mark-approval-for-BrainSense-TM-Adaptive-deep-brain-stimulation-and-Electrode-Identifier,-a-groundbreaking-advance-in-personalized,-sensing-enabled-care-for-people-with-Parkinsons-through-innovative-brain-computer-interfac
2. Stanslaski S, Summers RLS, Tonder L, et al. Sensing data and methodology from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) clinical trial. Npj Parkinson’s. Published 2024;10(174). doi:10.1038/s41531-024-00772-5
3. Medtronic receives landmark FDA approval for asleep deep brain stimulation surgery. News release. Medtronic. August 12, 2024. Accessed January 13, 2025. https://news.medtronic.com/2024-08-12-Medtronic-receives-landmark-FDA-approval-for-Asleep-Deep-Brain-Stimulation-surgery