Medtronic earns U.S. FDA approval for world's first adaptive deep brain stimulation system

For the one million people diagnosed with Parkinson's disease in the United States, Medtronic announces U.S. Food and Drug Administration (FDA) approval of BrainSense™ Adaptive deep brain stimulation (aDBS) and BrainSense™ Electrode Identifier (EI).

There is no cure for debilitating neurological conditions like Parkinson's, however, deep brain stimulation (DBS) has been transforming the lives of people with Parkinson's and other neurological disorders for more than 30 years. DBS is similar to a cardiac pacemaker but for the brain. It uses a surgically implanted neurostimulator via a minimally invasive procedure to transmit electrical signals to specific parts of the brain affected by debilitating neurological disorders.

Now Medtronic has enhanced its Percept™ DBS neurostimulators with exclusive BrainSense™ Adaptive technology, introducing aDBS for people living with Parkinson's. This feature personalizes therapy based on a patient's brain activity in real time – both in clinical settings and in daily life. It provides enhanced therapy personalization for symptom control that automatically adjusts, minimizing the need for patients to manually adjust stimulation.

For more than ten years, Medtronic has been developing a complete, sensing-enabled DBS system leveraging exclusive BrainSense™ technology to detect, capture, and classify different brain signals, putting Medtronic at the forefront of incorporating brain-computer interface (BCI) technology into DBS therapy. Medtronic considers BCI technology a crucial element for developing innovative products that treat some of the cardinal symptoms of Parkinson's with specific focus on rehabilitation and restoring health. BrainSense™ Adaptive DBS is available to Medtronic DBS patients with Parkinson's who have been implanted with a Percept™ neurostimulator, as well as future Medtronic DBS patients. With more than 40,000 DBS patients served worldwide with Medtronic Percept™ devices, BrainSense™ Adaptive DBS presents the largest commercial launch (by several magnitudes) of BCI technology – ever.

The Medtronic Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial highlights 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), and 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 both clinical and home settings and was developed in collaboration with more than a dozen world-renowned 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 U.S. FDA approval also includes the Medtronic BrainSense™ Electrode Identifier (EI), which helps reduce patient time spent in clinic to program their DBS settings. By using EI, clinicians can conduct an accurate and precise initial programming, 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 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 and associate professor of neurology at the University of Colorado School of Medicine.

Learn more