Medtronic's DBS therapy gains expanded FDA approval in Parkinson's disease

Medtronic announced Wednesday that its deep brain stimulation (DBS) therapy received expanded FDA approval for use in people with at least four years history of Parkinson's disease and with recent onset of motor complications, or a longer duration of motor complications that are not adequately controlled with medication.

The company noted that the latest approval was based on data from the EARLYSTIM study, which found that patients treated with DBS therapy and best medical therapy (BMT) reported a mean improvement of 26 percent in their disease-related quality of life at two years, versus a one percent decline in those treated with BMT alone. Moreover, study data from patients with longer-standing motor complications showed DBS improved patients' quality of life by 20 percent from baseline to six months compared to no improvement in those treated with BMT alone.

Lothar Krinke, Medtronic's general manager of the Brain Modulation business said the latest "approval is important because it expands the therapeutic window when patients can benefit from DBS." Krinke added DBS "can now be used sooner in the care continuum, giving patients with recent onset motor complications another option to maintain or restore quality of life." The FDA initially approved Medtronic's DBS therapy in 2002 for use in patients with advanced Parkinson's disease.

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