JPM25: Medtronic begins rolling out adaptive brain stimulation for Parkinson’s after EU approval

 While deep-brain stimulation therapy has been available for people with Parkinson’s disease for decades, Medtronic has now received a European approval for what it describes as the first closed-loop therapy approach—allowing for self-adjusting neuromodulation in real time to help control the condition’s motor symptoms.

The CE Mark approval allows the company to begin rolling out the treatment immediately, essentially as a software update, to current patients who have already received its Percept neurostimulator implants equipped with BrainSense technology.

Indeed, Medtronic reported that the first European patient’s reprogramming to enable the feature was completed January 13, the same day as the company’s announcement, at Amsterdam University Medical Center.

“This is an area where the investments we've made over the past several years in sensing technology in the brain and the nervous system are now paying off,” Medtronic CEO Geoff Martha said during the company’s presentation at the J.P. Morgan Healthcare Conference in San Francisco.

“Sensing and closed-loop technology are becoming foundational to the neuromod space—if anybody tells you different, they don't know what they're talking about,” Martha said.

The company’s BrainSense algorithms measure changes in a patient’s neural activity and then help tailor stimulation therapy on a personalized basis. Last September, Medtronic offered a view into an at-home, real-world study of the adaptive technology—showing that it was able to time its doses to help avoid the side effects that can come when stimulation and peak medication levels overlap.

The closed-loop approach is currently under review at the FDA. Medtronic estimates that Parkinson’s disease affects more than 1.2 million people in Europe and the U.K., and over 10 million people globally.

“This has been categorized as a brain-computer interface technology… [and from that] perspective, we already have 40,000 patients on this,” Martha said during the presentation. “That makes it—by orders of magnitude—the largest, most-scaled BCI technology in the world.”

https://www.fiercebiotech.com/medtech/jpm25-medtronic-begins-rolling-out-adaptive-brain-stimulation-parkinsons-after-eu-approval