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# FDA Expanded Approval for Medtronic Brain Stimulator
- URL: https://www.fdaweb.com/fda-expanded-approval-for-medtronic-brain-stimulator/
- Published: 2016-02-18T12:00:00.000Z
- Updated: 2026-09-15T02:37:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134813

> FDA has approved Medtronic’s Deep Brain Stimulation (DBS) therapy for use in people with Parkinson’s disease of at least four years duration and with recent onset of motor complications, or motor complications that are not adequately controlled with medication. The device was originally approved in 2002 for use in patients with advanced Parkinson’s disease. The company says it has demonstrated improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in individuals with Parkinson’s.  
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> The latest approval was based on data from the EARLYSTIM clinical study, which was published in the *New England Journal of Medicine* in 2013\. The study found that patients treated with DBS therapy and “best medical therapy” (BMT) reported a mean improvement of 26% in their disease-related quality of life at two years, compared to a 1% decline in patients treated with BMT alone, Medtronic says. “In a study of patients with longer-standing motor complications, DBS patients’ quality of life improved 20% from baseline to six months compared to no improvement in the patients treated with BMT alone,” it says.