Medtronic Gains CE Mark for BrainSense Adaptive Deep Brain Stimulation and Electrode Identifier

Medtronic received CE Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI). 

Achieving the standards required by the EU Medical Device Regulation (MDR) and first-in-Europe patient programming demonstrate significant advancements in personalized DBS therapy for people with Parkinson’s in Europe and the UK.

Deep brain stimulation (DBS) is a technology that transmits electric signals to the brain to disrupt certain unwanted movements.

With BrainSense aDBS, people with Parkinson’s disease can now benefit from real-time, adaptive therapy that dynamically adjusts stimulation based on each person’s unique brain activity in clinical settings and daily life¹. The Medtronic Percept DBS system with BrainSense technology is designed to record and analyze brain signals, enabling therapies tailored to each patient’s neurological patterns¹. 

“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,” said Paolo Di Vincenzo, president of the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. “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, and we’re just getting started. The mission is to impact and improve many more lives with Medtronic DBS therapy.”

Medtronic’s BrainSense Electrode Identifier (EI) elevates precision and efficiency to unprecedented levels by providing a detailed view of each Parkinson’s patient’s unique brain signals and guiding clinicians to the exact location of the strongest signal in a fraction of the time needed for standard monopolar reviews². 

This technology pinpoints the optimal contact location by leveraging local field potentials (LFP) and alpha-beta activity to guide optimized and effective programming compared to the standard of care, the monopolar review².

The Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) trial highlighted the potential of aDBS in clinical practice. Conducted as a global, multi-center, prospective, single-blind randomized crossover study (between two modes of aDBS), the trial evaluated the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson’s patients receiving DBS therapy. 

This study represents the largest and longest assessment of aDBS conducted in clinical and home settings¹. The study methodology and sensing data from the Medtronic study were published in npj Parkinson’s Disease, a journal within the Nature Portfolio.

Also, the first programming was completed, performed by Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. 

“Adaptive deep brain stimulation represents an exciting evolution in how we manage Parkinson’s,” said Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, 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.”

BrainSense aDBS and BrainSense Electrode Identifier will be available in Europe in early 2025. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution.

References:

¹ Thompson, J., Radcliffe, E., Ojemann, S.,et al. Monopolar sensing improves the efficiency of DBS programming in Parkinson’s disease [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/monopolar-sensing-improves-the-efficiency-of-dbs-programming-in-parkinsons-disease/. Accessed 11/15/2024

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 Parkinsons Dis. 2024;10(1):174.

† The sensing feature of the Percept PC and Percept RC system is intended for use in patients receiving DBS where chronically recorded bioelectric data may provide useful, objective information regarding patient clinical status.