FDA Approves Rechargeable Neurostimulator to Treat Movement Disorders

The US Food and Drug Administration (FDA) approved Medtronic’s Percept RC deep brain stimulation (DBS) system, a rechargeable neurostimulator that features a sensing-enabled DBS system for personalized treatment of movement disorders such as Parkinson disease, essential tremor, dystonia, and epilepsy.

“Our DBS therapy…can help control debilitating tremors for people living with Parkinson, providing patients with the ability to physically engage in everyday moments,” said Amaza Reitmeier, vice president and general manager, Brain Modulation within the Neuromodulation business, Medtronic, in a press release.

Now the smallest and thinnest dual-channel neurostimulator available for DBS, Percept RC uses technology to capture and record brain signals that provide insights that allow the health care provider to adapt and personalize treatment, the manufacturer says. The device battery promises to last at least 15 years and patients can “rapid recharge” from 10% to 90% in less than 1 hour.

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The system is unique in its compatibility with magnetic resonance imaging (MRI), a crucial aspect for patients requiring essential care. “Nearly 70% of all DBS-eligible patients are estimated to require an MRI as part of their essential care,” noted the press release.

“While more data are needed, the sensing capability of this unique deep brain stimulation system allows me the potential to tune stimulation delivery to brain activity, which may be a way to personalize this therapy for Parkinson disease in the future," said Casey H. Halpern, MD, Division Head, Functional and Stereotactic Neurosurgery, Penn Medicine, Philadelphia.

The DMS feature aims to capture chronically recorded bioelectric data, providing “useful, objective information regarding patient clinical status.” While most Parkinson disease patients exhibit an identifiable signal, patients treated for essential tremor, dystonia, epilepsy, or obsessive-compulsive disorder (OCD) may not have a measurable signal. For dystonia and OCD, the effectiveness of these devices as humanitarian devices has not been demonstrated.

Reference

FDA approves Medtronic Percept™ RC neurostimulator with exclusive BrainSense™ technology. News Release. PR Newswire. January 8, 2023. Accessed January 12, 2023.