The expanded approval covers patients who have had a Parkinson’s diagnosis for 4 years and recently developed motor complications, or have long-standing motor complications that can’t be controlled with drugs. The original FDA approval for Medtronic’s DBS for Parkinson’s covered patients in the advanced stages of the disease, the Fridley, Minn.-based company said.
Medtronic said the new approval is based on results from its Earlystim trial showing a 26% mean improvement at 2 years in patients treated with DBS and best medical therapy, compared with a -1% decline in patients treated with BMT alone.
“Parkinson’s disease is progressive, and as a result a patient’s quality of life will deteriorate over time. This approval is important because it expands the therapeutic window when patients can benefit from DBS,” brain modulation general manager Lothar Krinke said in prepared remarks. “Medtronic’s goal is to advance medical care and deliver the best possible patient outcomes. DBS is proven to provide long-term benefits and it 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.”
“Strong clinical evidence demonstrates that, when compared to the best medical treatment alone, Medtronic DBS therapy offers Parkinson’s patients with recent onset of motor fluctuations and dyskinesias not adequately controlled with medication a higher likelihood of symptom improvement. Historically, the therapy has often not been considered until symptoms have had a significant impact on quality of life,” added Dr. Mahlon DeLong of the Emory University School of Medicine. “This decision by the FDA is significant in that Medtronic DBS therapy may be considered before the symptoms and complications of disease become severe. Parkinson’s patients should be referred to an experienced DBS multidisciplinary center for a comprehensive evaluation of possible Medtronic DBS therapy. For patients who are still functioning socially and able to work, this may translate into improved quality of life and an overall reduction of the burden of disease.”