Medtronic has announced CE Mark approval in the European Union and the United Kingdom for its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI), having achieved the standards required by the EU Medical Device Regulation (MDR).
In addition, the first programming was completed, performed by Martijn Beudel, MD, PhD, neurologist and associate professor, Department of Neurology, Amsterdam University Medical Center. According to the company, this approval and first-in-Europe patient programming demonstrate significant advancements in personalised DBS therapy for Parkinson’s patients in Europe, including the UK.
For 30 years, patients with Parkinson’s disease have benefitted from deep brain stimulation (DBS), a technology that transmits electric signals to the brain to disrupt unwanted movement. With BrainSense aDBS, patients with Parkinson’s disease can now benefit from real-time, adaptive therapy that dynamically adjusts stimulation based on each patient’s unique brain activity, both in clinical settings and daily life.BrainSense Electrode Identifier can improve DBS programming by ensuring optimal contact selection in less time.
Caregivers and healthcare providers alike intimately understand how disruptive Parkinson’s can be on one’s daily life. Affecting over 1.2 million patients in Europe alone and more than 10 million people worldwide, Parkinson’s is known to impact an individual’s mobility, speech, focus, sleep, independence, and overall ability to participate fully in work, family, and social life.
From sipping a cup of coffee to holding hands with a loved one, the disease can be debilitating and demoralising, stripping away what many of us take for granted. For spouses and caregivers, this can be immensely demanding and distressing.
“BrainSense is at the center of personalizing DBS therapy, and we are advancing this capability through innovation that builds on our exclusive 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.”
The Medtronic Percept™ DBS system with exclusive BrainSense™ technology is designed to record and analyze brain signals, enabling therapies tailored to each patient’s unique neurological patterns1. Medtronic has been at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy with the specific purpose of making advances in prevention, detection, diagnosis, rehabilitation, and restoration for patients with complex neurological conditions. As the world leader in DBS therapy, the Medtronic Percept™ neurostimulators with BrainSense™ technology† serve as a benchmark for DBS sensing innovation.
“Adaptive deep brain stimulation represents an exciting evolution in how we manage movement disorders,” said Martijn Beudel. “By using real-time brain activity to automatically adjust stimulation, this technology enhances the ability to deliver patient-specific stimulation algorithms that can be adapted to an individual’s unique needs. The CE Mark approval underscores the potential of adaptive DBS to improve symptom management.”
Medtronic is the originator of continuous deep brain stimulation (cDBS), which has been available for decades as a proven therapy for managing Parkinson’s disease symptoms. BrainSense™ Adaptive DBS (aDBS) takes treatment to the next level, dynamically calibrating stimulation based upon a patient’s own brain signals1,2.
“Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients to live better with Parkinson’s and spend less time thinking about their disease,” said Amaza Reitmeier, Vice President and General Manager, Neuromodulation marketing and strategy at Medtronic. “Patients and clinicians have been eagerly awaiting these BrainSense technology enhancements, which represent another transformative step forward in our ability to personalise therapy for people living with Parkinson’s.”
The Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) trial further highlights the potential of aDBS in clinical practice. Conducted as a global, multi-centre, prospective, single-blind randomised crossover study (between two modes of aDBS), the trial evaluates the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to cDBS for eligible Parkinson’s patients receiving DBS therapy.
Developed in collaboration with more than a dozen world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, this study represents the largest and longest assessment of aDBS conducted in both clinical and home settings. The study methodology and sensing data from the Medtronic study were published in npj Parkinson’s Disease, a journal within the Nature Portfolio.
“The CE Mark approval of BrainSense Adaptive DBS is a critical advancement in how we treat Parkinson’s disease,” said Alan Whone, PhD, professor of movement disorders neurology, University of Bristol and North Bristol NHS Trust. “Its potential to address 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.”
BrainSense (EI) elevates precision and efficiency to unprecedented levels by providing a detailed view of each 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 reviews. This exclusive technology pinpoints the optimal contact location by leveraging local field potential (LFP) and alpha-beta activity to ensure the most accurate and effective programming possible.
“BrainSense Electrode Identifier allows clinicians to now conduct an accurate and precise initial programming, offering a level of personalisation 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. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world.”
Since 1987, Medtronic has served more than 185,000 patients with movement disorders and other indications in more than 70 countries with its life-changing DBS therapy.
BrainSense aDBS and BrainSense Electrode identifier will be available in Europe in early 2025. Patients considering DBS therapy should discuss treatment options with their provider. Medtronic has filed for U.S. FDA approval of aDBS; it is not yet approved for sale or distribution in the United States.
