Medtronic PLC announced Food and Drug Administration approval Wednesday to sell a deep-brain stimulation device that can treat complications from Parkinson's disease much earlier than before.
Medtronic's Deep Brain Stimulation (DBS) Therapy is like a pacemaker for the brain. It uses a pulse generator implanted in the chest and thin wires precisely placed in the brain to deliver electric signals that can reduce Parkinson's symptoms like shaking, stiffness and movement difficulties.
The DBS device has been FDA-approved to treat advanced Parkinson's since 2002. Wednesday's approval announcement expands the device's indications to include patients who have had the condition for at least four years but only recently experienced motor symptoms.
"Historically, the therapy has often not been considered until symptoms have had a significant impact on quality of life," Atlanta neurologist Dr. Mahlon DeLong said in a news release Wednesday. "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 is an expensive condition. Medtronic cited statistics from 2013 article the journal Movement Disorders that pegged the disease's annual economic impact at $14.4 billion, including direct medical costs and indirect costs from lost work.
"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," Medtronic Vice President Lothar Krinke said in the release.
Parkinson's disease is a progressive, incurable neurological disorder that affects about 1.5 million Americans.
It's typically treated with medications including levodopa, a drug that can create its own side effects that can be treated with a DBS system. DBS requires brain surgery, which carries risks of serious complications like coma, seizure and bleeding in the brain. A blinded analysis of patients in Toronto who used DBS for at least 10 years found benefits of the therapy after a decade despite potential surgical and device-related complications.
