Innovating Parkinson's Care: Key Takeaways from the CE Mark Approval of BrainSense aDBS

Amaza Reitmeier

Deep brain stimulation (DBS) is a neurosurgical procedure used to treat a variety of movement disorders, particularly Parkinson disease (PD), essential tremor, and dystonia. It involves implanting a small device, often referred to as a neurostimulator or brain pacemaker, into specific areas of the brain that control movement. Earlier this month, the European Union gave CE Mark approval to Medtronic’s BrainSense Adaptive DBS (aDBS) and BrainSense Electrode Identifier (EI), a pair of digital modalities designed to enhance PD care.

Each technology is a bit different: aDBS dynamically adjusts DBS in real-time based on patient-specific brain activity, enhancing therapy personalization whereas the EI optimizes initial DBS programming by precisely identifying the strongest signal location. The approval was based on data from the ADAPT-PD trial, a real-world, single-blinded, randomized prospective study of patients with PD. These data were also used in the company’s submission to the FDA, which remains currently in review.

Ashwini Sharan, MD

To better understand these technologies and their use in the clinical care of patients with PD, NeurologyLive® reached out to Amaza Reitmeier, vice president and general manager of Brain Modulation, a portion of the Neuroscience Portfolio at Medtronic, and Ashwini Sharan, MD, chief medical officer of Medtronic Neuromodulation. In the discussion, the duo provided more context on the transformative potential of these technologies in offering real-time adaptive therapy that can adjust to each patient’s unique brain signals. Additionally, Reitmeier and Sharan discussed how these innovations represent a shift toward a more dynamic, patient-centered approach to treat PD, which coupled with ongoing research and real-world data, will drive further improvements in treatment precision and patient quality of life.

What is the significance of this CE Mark approval for the BrainSense aDBS and EI? What does this mean for the patient and clinician community?

Amaza Reitmeier: The CE Mark approval for BrainSense™ Adaptive deep brain stimulation (aDBS) and the Electrode Identifier (EI) is a major milestone for advancing personalized care in Parkinson disease treatment. With aDBS, people with Parkinson now have access to real-time adaptive therapy that adjusts to their individual brain activity and improves symptom management while reducing side effects, enabling greater control over their daily lives. For clinicians, EI provides advanced tools to better understand brain activity which increases efficiency of programming and makes it easier to deliver therapies tailored to each patient’s unique needs. This approval highlights how far we've come in working with the medical community to bring meaningful innovations to patient lives. Ultimately, it represents a significant step forward in making therapies adaptive, personalized, and accessible to those who need them.

How do each of these systems operate?

Ashwini Sharan, MD: BrainSense™ aDBS records real-time brain signals, called local field potentials (LFPs), and automatically adjusts stimulation to manage symptom fluctuations, providing personalized therapy. This reduces side effects, improves symptom control, and may extend battery life. BrainSense™ Electrode Identifier streamlines the programming process by helping clinicians quickly identify the most effective electrode contact with greater accuracy. Together, these systems enhance efficiency, precision, and personalization in DBS therapy. They represent a dynamic, patient-focused approach to improving outcomes for people with Parkinson disease.

How has DBS operations improved over the years? Not just the progress made for these products, but for the field as a whole.

Amaza Reitmeier: Medtronic is the originator of continuous deep brain stimulation (cDBS), which has been available for decades as a proven therapy for managing many symptoms of movement disorders such as Parkinson and Essential Tremor. BrainSense™ Adaptive DBS (aDBS) takes treatment to the next level, dynamically calibrating stimulation based upon a patient's own brain signals. Over the years, we've made advancements that have made the therapy more accessible and effective for patients. The ability to sense brain activity and adapt stimulation in real time, as with BrainSense™ aDBS, is a great example of how technology has evolved to meet individual patient needs. Beyond the products, the collaboration between clinicians, engineers, and researchers has driven the entire field forward. It’s exciting to see how these innovations are not just treating symptoms but also helping patients reclaim parts of their lives they may have thought were lost. Additionally, 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. In fact, with 40K patients with Medtronic Percept devices worldwide and commercial approval of BrainSense™ Adaptive deep brain stimulation, Medtronic is poised to have the broadest commercial launch (by several magnitudes) of BCI technology – ever.

What were some of the most notable supportive data for this CE mark?

Ashwini Sharan, MD: The CE Mark approval of BrainSense™ aDBS and BrainSense™ Electrode Identifier was backed by robust data from the ADAPT-PD trial, the largest and longest study of adaptive DBS. This trial demonstrated safety and effectiveness across clinical and home settings, showcasing the potential of adaptive DBS to deliver personalized therapy. The methods were published in npj Parkinson Disease. The results of the ADAPT-PD trial are expected to support the global regulatory submissions to commercialize aDBS for people living with PD.

Is there any way we can continue to improve/enhance these tools going forward?

Ashwini Sharan, MD: As real-world data continues to emerge, there is significant opportunity to further refine the adaptive algorithm, optimizing when and how stimulation is delivered. Ongoing research partnerships with academic institutions will deepen the integration of sensing technology into clinical practice, enabling even more precise, responsive therapies. These efforts may unlock new applications for DBS and expand its benefits to broader patient populations. Ultimately, this commitment to innovation will drive greater personalization, improve symptom control, and enhance quality of life for individuals living with neurological disorders.