New Device for Parkinson’s disease and Essential Tremor Got Approval from US FDA

The US FDA has given acceptance to an implantable brain stimulation device for decreasing the symptoms of Parkinson’s disease and essential tremor when drugs alone are not able to offer enough relief.brain

The Brio Neurostimulation System is the 2nd device to be accepted by the US FDA for treating these problems and can decrease symptoms like as balance issues, tremors and walking complications.

Dr. William Maisel of the FDA states that

There is no permanent cure for Parkinson’s disease or essential tremor, but discovering superior ways to handle symptoms is important for sufferers. This new device adds to the range of therapy choices to help patients living with Parkinson’s and essential tremor enjoy better, more successful lives.”

About one million individuals in the US are considered to have Parkinson’s disease, with an approximated 50,000 people newly diagnosed with this condition every year.

Parkinson’s disease symptoms are triggered by the degeneration of nerve cells that make the neurotransmitter dopamine, a chemical that assists transmit information from the brain related to the control and co-ordination of body activities.

The cause of essential tremor is presently unidentified, but the problem leads to involuntary shaking – commonly in the hands – that is very similar to that triggered by Parkinson’s disease. The problem affects several million individuals in the US, generally over the age of 40.

Drugs are often used to decrease tremors in individuals with Parkinson’s condition and essential tremor, but often medication is not able to properly alleviate disruptive symptoms. When this is the case, the new Brio Neurostimulation System could be of use.

A battery powered generator that delivers electrical pulses to the brain

Produced by St. Jude Medical in St. Paul, MN, the device comprises of a small electrical pulse generator inserted under the skin of the upper chest. The generator is linked to electrodes placed within the brain according to whether the device is being used to deal with Parkinson’s disease or essential tremor.

The battery powered pulse generator is totally rechargeable and provides low-intensity electrical pulses to these electrodes via wires. Health care professionals can adjust the activity of the pulse generator to be able to maximize the effects for the sufferers using the device.

Among the data provided to the FDA to show the safety and efficacy of the device were two clinical trials: one including 136 patients with Parkinson’s condition and one including 127 sufferers with essential tremor.

In both trials, the individuals were experiencing tremors that were not being effectively treated by medicine. After 3 months for the sufferer with Parkinson’s disease and 6 months for the sufferers with essential tremor, the investigators evaluated the effectiveness of the device.

For both groups of sufferers, considerable enhancement in symptoms was observed when the device was turned on in comparison with when the device was turned off. In the sufferers with Parkinson’s disease, the device was used together with medication while the greater part of sufferers with essential tremor could manage their symptoms without further drug treatment.

A number of adverse events associated to use of the device were noticed by investigators. These ranged from infection and dislocation of the device within the skin to more serious events like as intracranial bleeding. These events took place rarely, however, for the US FDA say yes to this new device.