A panel of scientific advisers has unanimously recommended that the Food and Drug Administration approve a pacemaker-like brain implant to help Parkinson's patients who do not get relief from drugs.
The FDA is not bound by the panel's advice but usually follows it.At least 500,000 Americans have Parkinson's disease, a degenerative neurological disorder that causes uncontrollable shaking. In addition, about 2 million Americans have "essential tremor," a hereditary disease that causes similar violent shaking.
The "Activa system" brain implant device is manufactured by Medtronic of Minneapolis.
It works this way: Doctors drill through the skull and implant an electrode into the brain. A wire runs just under the scalp down to the collar bone, where a pacemaker-size pulse generator is implanted. It sends electric waves to the electrode, which blocks tremors by emitting a constant stream of tiny electric shocks.
About 2,000 European patients have received the Activa implants since 1995.
Studies show that the device works best for those patients with essential tremors. In a recent study of 120 patients, about half of the patients with Parkinson's improved with the implant, although some of their conditions worsened a year later.
The implant, including surgery, costs about $25,000.