The FDA offered Medtronic ($MDT) a broader approval for its deep brain stimulator to treat Parkinson's disease. The expansion will put it roughly on par with a PMA approval for St. Jude Medical's ($STJ) Brio that came last June.
Medtronic Deep Brain Stimulation (DBS) Therapy to treat Parkinson's disease was initially FDA approved in 1997 for tremor associated with essential tremor and Parkinson's disease. In 2002, the indications were expanded to include patients with advanced Parkinson's disease.
The latest indication expansion includes patients who have had Parkinson's disease for at least four years and with recent onset of motor complications, or those with motor complications of longer-standing duration that are not adequately controlled with medication.
But Medtronic and St. Jude may not be neck-and-neck in the U.S. for long. For its part, in September St. Jude won a CE Mark for its next-gen Infinity DBS system for movement disorder, including Parkinson's patients, with a directional lead that can be managed by patients and programmed by healthcare providers via Apple ($AAPL) smart devices, rather than a dedicated controller.
DBS systems include a small pacemaker-like implant in the chest that is connected via lead wires to the brain and managed via an external controller. They provide regular electrical stimulation. Ultimately, the ideal for DBS stimulators is to offer stimulation only as needed by the particular patient rather than continuously, as is now the case. Medtronic noted that its DBS has shown improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in Parkinson's patients.
"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," said Dr. Mahlon DeLong, a professor of neurology at Emory University School of Medicine in a statement.
In a study of patients treated with Medtronic 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.
Concluded DeLong, "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."
- here is the announcement