Medtronic Secures FDA Approval for BrainSense Adaptive DBS, Advancing Personalized Parkinson's Treatment

For more than 30 years, Deep Brain Stimulation (DBS) has provided relief for individuals who have Parkinson's disease and other debilitating neurological disorders.

Medtronic plc, a Galway-headquartered global leader in healthcare technology, has announced that the US Food and Drug Administration (FDA) has approved its BrainSense Adaptive Deep Brain Stimulation (aDBS) system and the BrainSense Electrode Identifier (EI).

This cutting-edge, closed-loop system automatically adjusts DBS therapy based on real-time brain activity, marking the largest commercial launch of brain-computer interface (BCI) technology to date.

For more than 30 years, Deep Brain Stimulation (DBS) has provided relief for individuals who have Parkinson's disease and other debilitating neurological disorders.

While there is currently no cure for Parkinson's, DBS functions similarly to a cardiac pacemaker, transmitting electrical signals to targeted brain areas through a surgically implanted neurostimulator.

This minimally invasive approach has already transformed patient care, and Medtronic's new adaptive technology aims to take treatment to the next level.

Enhancing DBS with Adaptive Technology

Medtronic has incorporated its exclusive BrainSense Adaptive technology into its Percept DBS neurostimulators, bringing the next generation of DBS therapy to patients with Parkinson's disease.

Unlike traditional DBS, which requires manual adjustments, the new aDBS system automatically personalizes therapy in real-time, both in clinical settings and in daily life.

This advancement ensures that patients receive optimized symptom control without manually tweaking stimulation levels.

"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 Medtronic's Neuroscience Portfolio.

"This new era in Parkinson's care represents more than a decade of intentional innovation—ushering in personalized neuromodulation at a scale that responds to a patient's changing needs, equips clinicians with unparalleled insights, and sets a new standard for DBS therapy."

The Role of BrainSense Technology in DBS

Medtronic has been developing a sensing-enabled DBS system using its proprietary BrainSense technology for over a decade.

This system detects, captures, and classifies various brain signals, positioning Medtronic at the forefront of brain-computer interface (BCI) integration within DBS therapy.

BCI technology is a key component of Medtronic's long-term innovation strategy, aiming to treat the core symptoms of Parkinson's disease.

The BrainSense Adaptive DBS system is now available for existing Medtronic DBS patients implanted with a Percept neurostimulator, as well as for future Medtronic DBS recipients.

Experts in neurology and movement disorders have hailed adaptive deep brain stimulation as a game-changer in Parkinson's therapy.

Dr. Helen Bronte-Stewart, Director of the Human Motor Control and Neuromodulation Lab at Stanford University School of Medicine, emphasized the impact of aDBS on therapeutic treatment approaches.

"Adaptive deep brain stimulation will revolutionize treatment for patients with Parkinson's disease," said Dr Bronte-Stewart.

"Automatic adjustment of therapy greatly benefits patients by responding to their evolving needs in real-time."

Clinical Trials Validate aDBS Benefits

The potential of aDBS in clinical practice was extensively studied in a global trial led by Dr. Bronte-Stewart. The ADAPT-PD study, the largest and longest evaluation of aDBS, was conducted in both clinical and home environments.

It was designed as an international, multicenter, prospective, single-blind, randomized crossover study comparing the effectiveness of chronic dual- and single-threshold aDBS modes to continuous DBS (cDBS) for Parkinson's patients.

The trial included world-renowned neurologists and neurosurgeons from leading institutions such as:

Stanford University School of Medicine

University of California, San Francisco

Massachusetts General Hospital

Amsterdam University Medical Center

The study's results indicate that aDBS may provide superior symptom control for patients experiencing motor fluctuations, dyskinesias, and other side effects from continuous DBS.

Dr Todd Herrington, Director of the Deep Brain Stimulation Program at Massachusetts General Hospital and Assistant Professor of Neurology at Harvard Medical School, highlighted the importance of the FDA's approval.

"For patients struggling with motor symptom fluctuations, aDBS may offer improved symptom control," Dr. Herrington noted. "This approval is a major step forward, and we look forward to publishing the ADAPT-PD study results soon."

Streamlining Patient Care with BrainSense Electrode Identifier (EI)

In addition to aDBS, Medtronic's BrainSense Electrode Identifier (EI) has also received FDA approval. This innovative tool is designed to significantly reduce patient time in clinics by simplifying DBS programming.

Traditional electrode selection methods can be time-consuming and ambiguous, whereas EI accelerates the process by up to 85%, allowing clinicians to achieve precise, real-time programming with greater efficiency.

Dr Drew Kern, a Neurologist and Associate Professor at the University of Colorado School of Medicine, emphasized the new method's benefits.

"BrainSense Electrode Identifier provides a personalized, real-time snapshot of a patient's brain signals," Dr Kern explained. "This allows clinicians to quickly determine the optimal electrode placement, reducing selection time and ensuring more accurate, tailored therapy for each patient."

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