Medtronic has announced US Food and Drug Administration (FDA) approval of its BrainSense adaptive deep brain stimulation (aDBS) and the BrainSense electrode identifier.
Through this approval, Medtronic says it has enhanced its Percept DBS neurostimulators with exclusive BrainSense adaptive technology, introducing aDBS for people living with Parkinson’s disease and providing therapy that is personalised in real time based on a patient’s brain activity—both in clinical settings and in daily life. The company notes that this enhanced therapy personalisation enables symptom control that automatically adjusts, minimising the need for patients to manually adjust stimulation.
Medtronic also claims that its ADAPT-PD trial highlights the potential of aDBS in clinical practice. This international, multicentre, prospective, single-blind, randomised crossover study evaluated the safety and effectiveness of chronic dual- and single-threshold aDBS modes compared to continuous DBS (cDBS) for eligible patients with Parkinson’s disease receiving DBS therapy. The study represents the largest and longest assessment of aDBS conducted in both clinical and home settings, having been developed in collaboration with several world-renowned neurologists and neurosurgeons from leading academic institutions across the globe, according to a recent press release from Medtronic.
“Adaptive deep brain stimulation will help revolutionise the approach to therapeutic treatment for patients with Parkinson’s disease,” said Helen Bronte-Stewart (Stanford University School of Medicine, Stanford, USA), global principal investigator for the ADAPT-PD trial. “The transformative personalised care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs.”
“For patients who struggle with motor symptom fluctuations, dyskinesias, and other side-effects with cDBS, aDBS may offer improved symptom control,” added ADAPT-PD investigator Todd Herrington (Massachusetts General Hospital, Boston, USA). “Approval of this therapy represents an important step forward for patients and I look forward to seeing the ADAPT-PD study results published soon.”
Medtronic states that, for more than 10 years, it has been developing a complete, sensing-enabled DBS system leveraging exclusive BrainSense technology to detect, capture and classify different brain signals, putting the company at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy. BrainSense aDBS is available to Medtronic DBS patients with Parkinson’s who have been implanted with a Percept neurostimulator, as well as future Medtronic DBS patients. The company’s recent release notes that—with more than 40,000 DBS patients worldwide receiving Medtronic Percept devices—BrainSense aDBS presents “the largest ever commercial launch (by several magnitudes) of BCI technology”.
The recently announced US FDA approval also includes the Medtronic BrainSense electrode identifier, which helps reduce time spent by patients in clinic to programme their DBS settings. By using the electrode identifier, clinicians can conduct an accurate and precise initial programming that Medtronic claims is 85% faster compared to traditional electrode selection.
“BrainSense electrode identifier offers less ambiguity and greater efficiency compared to the traditional method of electrode selection by providing a personalised, real-time snapshot of a patient’s brain signals, which can help provide insights into the proximal sweet spot for programming,” commented Drew Kern (University of Colorado School of Medicine, Aurora, USA). “This new method reduces initial contact selection time, streamlining the process and ensuring more precise, tailored therapy for each patient.”
“Our BrainSense technology provides unique and clinically important insights that no other DBS system can offer, using a person’s own brain signals to provide a window into their condition—in real time, over time,” added Paolo Di Vincenzo, president of the neuromodulation business, which is part of the neuroscience portfolio, at Medtronic. “Our focus has always been on creating solutions that work for real lives, not just standalone symptoms; aDBS reflects that commitment, bringing a new expectation in Parkinson’s treatment.”
“Medtronic is the only company in the world to offer an adaptive DBS system that dynamically adjusts therapy in real time,” said Brett Wall, executive vice president and president of the Medtronic neuroscience portfolio. “This new era in Parkinson’s care represents more than a decade of intentional innovation, ushering in personalised neuromodulation at scale that responds to a patient’s changing needs, equipping clinicians with unparalleled insights, and setting a new standard for DBS therapy.”
“Our dedication to advancing DBS research and innovation has transformed therapeutic options for individuals with movement disorders and epilepsy,” stated Amaza Reitmeier, vice president and general manager of the neuromodulation portfolio at Medtronic. “With this FDA approval, which quickly followed our CE mark, we are taking another significant step forward in delivering sensing-enabled personalised treatments to people with Parkinson’s.”
