Medtronic Earns U.S. FDA Approval for Adaptive Deep Brain Stimulation System for Parkinson’s

Medtronic has announced U.S. Food and Drug Administration (FDA) approval of BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI), the world’s first Adaptive Deep Brain Stimulation System for people with Parkinson’s.

Medtronic has enhanced its Percept DBS neurostimulators with its BrainSense Adaptive technology†, introducing aDBS for people living with Parkinson’s. It provides enhanced therapy personalization for symptom control that automatically adjusts, minimizing the need for patients to manually adjust stimulation.

“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 personalized neuromodulation at scale that responds to a patient’s changing needs, equipping clinicians with unparalleled insights, and setting a new standard for DBS therapy.”

The Medtronic Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD) trial highlighted the potential of aDBS in clinical practice. Dr. Bronte-Stewart served as the global principal investigator for the trial, which was conducted as an international, multi-center, prospective, single-blind, randomized crossover study (between two modes of aDBS). Dr. Bronte-Stewart also 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. 

This study represents the largest and longest assessment of aDBS conducted in clinical and home settings and was developed in collaboration with neurologists and neurosurgeons from leading academic institutions across the globe including Stanford University School of Medicine, University of California San Francisco, Massachusetts General Hospital and Amsterdam University Medical Center. 

The study methodology and sensing data from the study were published in npj Parkinson’s Disease, a journal within the Nature Portfolio.

“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,” said 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.”

The U.S. FDA approval also includes the Medtronic BrainSense Electrode Identifier (EI), which helps reduce patient time spent in the clinic to program their DBS settings. By using EI, clinicians can conduct accurate and precise initial programming that is 85% faster compared to traditional electrode selection¹.

“Our dedication to advancing DBS research and innovation has transformed therapeutic options for individuals with movement disorders and epilepsy,” said Amaza Reitmeier, vice president and general manager, 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 personalized treatments to people with Parkinson’s.”

BrainSense aDBS and EI are also available in Europe. Patient programs in the United States will begin at select healthcare systems over the coming weeks, with availability nationwide in the coming months.

Reference:

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 01/29/25