FDA Approves Medtronic DBS Therapy for Early PD

The Parkinson’s Disease Foundation (PDF) alerts the community that Medtronic deep brain stimulation (DBS) Therapy has been approved by the US Food and Drug Administration (FDA) for the treatment of Parkinson's disease (PD) in people with at least four years disease duration and with recent onset of motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication. The therapy was developed in the 1990’s and approved in 2002 for treatment in people living with advanced Parkinson’s disease. This new approval was announced by the manufacturer on February 17.

DBS is a therapy that involves surgically implanting electrical stimulators into the brain. Since its initial approval, it has become a standard surgical therapy for Parkinson’s disease, but it is not a cure and is not for every person with the disease. DBS is most effective for individuals who experience disabling tremors, wearing-off spells, slowness of movement and medication-induced dyskinesias.

Since its initial approval, additional studies have raised questions about possible benefits of the therapy for those in the earlier stages of Parkinson’s disease. The manufacturer states that this new FDA approval was based on data from the EARLYSTIM clinical study, published in the New England Journal of Medicine in 2013, which found that people with Parkinson’s disease who developed motor complications early in their disease course and were treated with Medtronic DBS Therapy and medication reported an improvement in their disease-related quality of life at two years, compared to people with PD treated with medication alone.

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