TUESDAY, Jan. 22 , 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has decided that a device that controls severe Parkinson's disease symptoms may be twice as good if it's used twice as much.
The FDA has given the go-ahead for Medtronic Inc. to market an implant for both sides of the brain in order to control many of the tremors brought on by Parkinson's disease.
Activa, a deep brain stimulation system, was first approved in 1997 for only one side of the brain, and logically, only one side of the body. But a series of tests and trials indicated that implanting it on both sides demonstrated marked improvement.
This transcript from the agency hearing in 2000 shows some of the testimony that the agency examiners took into account.
The Activa system is used for those Parkinson's patients who can't be treated merely by medication. The disease strikes about 1.5 million Americans, and symptoms include tremors, rigidity, slowness and difficulty in moving, and occasionally, a loss of intellectual capacity.
According to a Talk Paper issued by the FDA, the Activa system consists of electrodes that are implanted into the brain and connected by leads (wires) under the skin to a pulse generator implanted in the abdomen or chest. The pulse generator sends a constant stream of tiny electrical pulses to the brain, blocking tremors. When the device is implanted in both sides of the brain, two separate systems are used.
Here is the entire Talk Paper.
Medtronic has agreed to do some followup work and will conduct a three-year study to assess the effectiveness of the two-sides Activa system. And this site from Medtronic provides a question and answer section on how the implants work.
