FDA approves Medtronic deep brain stimulation for Parkinson's disease patients with early motor complications

Release date: 2016-03-14

Medtronic announced on March 8 that the US Food and Drug Administration (FDA) approved Medtronic Brain Deep Electrical Stimulation (DBS) therapy for the treatment of at least 4 years of illness and the onset of motor complications or motor complications. Patients with Parkinson's disease. In 2002, the FDA first approved Medtronic brain deep electrical stimulation therapy for the treatment of advanced patients with Parkinson's disease. The therapy has been shown to have positive clinical performance in improving exercise complications, quality of life, daily activity, and reducing drug use in patients with Parkinson's disease.

Exercise complications are caused by Parkinson's disease progression and/or levodopa drug side effects, which have a great impact on the social and psychological aspects of patients, and their impact on daily life is usually very serious. As the quality of life of patients and caregivers deteriorates, the cost of treatment and care increases. 37% of Parkinson's patients have left their jobs prematurely, 6 months earlier. In the United States, Parkinson's disease consumes at least $14.4 billion a year, and it is expected that by 2040, there will be more than twice as many patients with Parkinson's disease in the United States.

Dr. Mahlon DeLong, a professor of neurology at Emory University School of Medicine, suggests that strong clinical evidence suggests that Medtronic deep brain stimulation (DBS) therapy is not associated with early motor fluctuations and dyskinesia compared with best drug therapy (BMT). In patients with better control of Parkinson's disease, the likelihood of symptom improvement is higher. Previously, the therapy was usually considered only when the symptoms of the disease had seriously affected the quality of life of the patient. The FDA's decision is significant, meaning that we can consider using Medtronic deep brain stimulation before the patient's symptoms become severe. Patients with Parkinson's disease should be referred to a multidisciplinary center with extensive experience in deep brain stimulation to perform a comprehensive assessment of therapeutic adaptation. For patients who are still socially or workable, the therapy can help improve symptoms, improve quality of life, and reduce the overall financial burden of the disease.

The FDA approval was based on data from the EARLYSTIM clinical study, which was published in the 2013 New England Journal of Medicine. The study found that patients with Parkinson's disease who used Medtronic deep brain stimulation (DBS) combined with drug therapy (BMT) improved disease-related quality of life by an average of 26% two years later; patients treated with BMT alone decreased by 1%. . In terms of long-term motor complications, the quality of life of patients receiving DBS therapy improved by 20% compared with baseline at 6 months; there was no improvement with BMT alone.

Dr. Lothar Krinke, vice president of Medtronic and head of the brain regulation business of the Restorative Therapy Group, stressed: "Parkinson's disease is progressive, and the quality of life of patients will gradually deteriorate over time. The FDA approval is important. Because it expands the treatment window for patients who can receive DBS therapy," "Medtronic's goal is to improve medical care and improve patient clinical outcomes as much as possible. DBS therapy has proven to be effective for a long time and is now available during the treatment cycle. Early use provides an additional option for patients with early motor complications to maintain or restore quality of life."

Complications of exercise will reduce quality of life, and this effect is generally similar for patients with early or long-term motor complications. In the EARLYSTIM study, 85% of patients who received DBS and BMT therapy had a significant clinical improvement over the biennium, compared with 36% of those who received only BMT therapy. Of the BMT-only therapies, 30% experienced worsening after 24 months, compared with only 2% of patients in the DBS-treated group. The study also found that 61% of patients who received DBS therapy for two years had improved levodopa-induced complications, including dyskinesia and exercise fluctuations, while 13% of patients who received BMT only worsened. . At the same time, long-term studies have found that patients with Parkinson's disease who have a 10-year progression have benefited from DBS therapy, despite potential risks of surgery and device-related complications.

Source: China Economic Net

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