What is Parkinson’s disease? It is a disorder of certain nerve cells in the brain which produces a chemical messenger dopamine. Dopamine is a neurotransmitter in a part of the brain that directs and controls movements. In Parkinson’s disease, these dopamine producing nerve cells break down, dopamine levels drop, and brain signals directing movement are abnormal.
The device is developed by St. Jude Medical and is called Neurostimulation System.
It is the second brain implant device which has been approved by FDA. The first brain implant device approved by FDA was Medtronic’s Activa Deep Brain Stimulation Therapy System in 1997.
The symptoms of parkinson’s disease are shaking or tremor of the limbs (arms and legs), stiff muscles or rigidity, and slow movement or bradykinesia.
The new device is designed to help patients with neurological conditions who are still experiencing symptoms even though they are on medications.
Dr. William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health said, “This new device adds to the array of treatment options to help people living with Parkinson’s and essential tremor enjoy better, more productive lives.”
This new device can be implanted under the skin of the upper chest with wires that run up to electrodes inside the brain of the patients. The implant is powered by battery and it will send electrical pulses to brain to regulate constant stimulation.
Researchers have tested the device efficiency and effectiveness on 136 Parkinson’s disease patients as well as on 127 patients with essential tremor. The participants had all been prescribed medication but were still experiencing symptoms.
Some of this group also used the medication along with the device.
FDA stated that “Both groups showed statistically significant improvement on their primary effectiveness endpoint when the device was turned on, compared to when it was turned off.”