(RxWiki News) The US Food and Drug Administration (FDA) has approved an easy-to-use device to treat pain associated with episodic cluster headaches.
This new approval is found under the name gammaCore. It's a nonsurgical option that provides electrical stimulation to the vagus nerve through the skin, which then reduces pain.
This device is hand-held and is applied at the neck. gammaCore stimulates the nerves and, in turn, changes the pain signals, according to electroCore, the maker of the device. This device is approved to be used to treat the symptoms as often as need be.
The approval of gammaCore comes after two clinical trials.
Although cluster headaches are rare, they can be very painful and difficult to manage. gammaCore may be a treatment option for the 400,000 people in the United States who have been diagnosed with cluster headaches, according to electroCore.
This device may not be safe for everyone. Children and pregnant women are not recommended to use gammaCore. In addition, adults who have significant high or low blood pressure or significant high or low heart rate, as well as those with an active implantable medical device like a hearing aid or pacemaker, are not recommended to use this device.
Speak with your health care provider about the best treatment option for your cluster headaches.
gammaCore is already available in Europe and is expected to be available in the US later this year.