FDA Approves Medtronic’s BrainSense Adaptive Deep Brain Stimulation for Parkinson Disease

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The FDA has approved Medtronic’s BrainSense adaptive deep brain stimulation (aDBS) system and BrainSense Electrode Identifier (EI) in patients with Parkinson disease (PD). According to the company, the aDBS system, which is integrated with Medtronic’s Percept DBS neurostimulators, personalizes therapy by dynamically adjusting stimulation based on real-time brain activity to improve symptom control without the need for manual adjustments. Approval was based on results from the ADAPT-PD trial, the largest and longest study of aDBS to date.¹

"Adaptive deep brain stimulation will help revolutionize the approach to therapeutic treatment for patients with Parkinson's disease," said Helen Bronte-Stewart MD MSE, FAAN, FANA, John E. Cahill family professor, department of neurology and neurological sciences, director of the human motor control and neuromodulation lab, Stanford University School of Medicine, in a press release. "The transformative personalized care we can achieve through automatic adjustment greatly benefits patients receiving therapy that adapts to their evolving needs."

The global, multi-center, prospective, single-blind, randomized ADAPT-PD crossover study evaluated the safety and effectiveness of chronic dual and single threshold aDBS modes. A total of 68 patients were monitored over the course of a year across four phases, such as baseline examination, initial aDBS set up and adjustment, evaluation, and long-term follow-up.²

According to Medtronic, the BrainSense EI streamlines DBS programming to reduce clinic time by 85% through real-time electrode selection.¹

"BrainSense Electrode Identifier offers less ambiguity and greater efficiency compared to the traditional method of electrode selection by providing a personalized, real-time snapshot of a patient's brain signals, which can help provide insights into the proximal sweet spot for programming. This new method reduces initial contact selection time, streamlining the process and ensuring more precise, tailored therapy for each patient," said Drew Kern, MD, MS, neurologist, associate professor of neurology at the University of Colorado School of Medicine, in the press release.

According to the Parkinson’s Foundation, approximately one million people are currently living with PD in the United States. Additionally, 90,000 people in the United States are diagnosed with PD annually. While the incidence of PD increases with age, an estimated 4% of all cases are in people under 50 years of age. Incidence rates are higher in the US Rust Belt region, as well as in Southern California, Southeastern Texas, Central Pennsylvania and Florida.

In a study titled Incidence of Parkinson’s Disease in North America, the results found that the risk of developing PD increased with age, which is also the primary risk factor. It is also more common in men, who are 1.5 times more likely to develop the disease than women.³

According to the World Health Organization, the prevalence of PD has doubled over the past 25 years, with 2019 global estimates indicating the disease resulted in 5.8 million disability-adjusted life years, an increase of 81% from 2000. Further, deaths increased by 100% since 2000, equal to 329,000 people.⁴

"For patients who struggle with motor symptom fluctuations, dyskinesias, and other side effects with cDBS, aDBS may offer improved symptom control," said Todd Herrington, MD, PhD, director, deep brain stimulation program, Massachusetts General Hospital, assistant professor of neurology, Harvard Medical School, and investigator for the ADAPT-PD trial, in the press release. "Approval of this therapy represents an important step forward for patients and I look forward to seeing the ADAPT-PD study results published soon."

References

1. Medtronic earns U.S. FDA approval for the world's first Adaptive deep brain stimulation system for people with Parkinson's. PR Newswire. February 24, 2025. Accessed February 24, 2025. https://www.prnewswire.com/news-releases/medtronic-earns-us-fda-approval-for-the-worlds-first-adaptive-deep-brain-stimulation-system-for-people-with-parkinsons-302382890.html

2. Medtronic pioneering ADAPT-PD clinical trial methods manuscript published, setting new standards in Parkinson's disease research. Medtronic. September 17, 2024. Accessed February 24, 2025. https://news.medtronic.com/Medtronic-pioneering-ADAPT-PD-clinical-trial-methods-manuscript-published,-setting-new-standards-in-Parkinsons-disease-research

3. Who has Parkinson's? Parkinson Foundation. Accessed February 24, 2025. https://www.parkinson.org/understanding-parkinsons/statistics#:~:text=Nearly%2090%2C000%20people%20in%20the,are%20diagnosed%20before%20age%2050.

4. Parkinson disease. WHO. August 9, 2023. Accessed February 24, 2025. https://www.who.int/news-room/fact-sheets/detail/parkinson-disease