What to Know About Migraine-Prevention Device

The U.S. Food and Drug Administration (FDA) on Oct. 14 approved a new implantable device for preventing migraine headaches. Here's what you should know about the device, called the gammaCore Sapphire:

How does it work?

The gammaCore Sapphire is a handheld, non-invasive device that delivers electrical stimulation to the vagus nerve, which is a long nerve that runs through the neck and connects the brain to the rest of the body. Stimulation of the vagus nerve has been shown to reduce the frequency and severity of migraine headaches.

Who is it for?

The gammaCore Sapphire is approved for use in adults aged 18 and over who have episodic migraines, which are defined as headaches that occur fewer than 14 days per month. The device is not for people with chronic migraines, which are headaches that occur 15 or more days per month.

How is it used?

The gammaCore Sapphire is held against the neck for two minutes. The device delivers electrical stimulation to the vagus nerve during that time. The patient may feel a tingling sensation during stimulation. The device can be used up to three times per day, as needed.

What are the side effects?

The most common side effects of the gammaCore Sapphire are pain, discomfort, or swelling at the site of stimulation. Other possible side effects include hoarseness, throat pain, cough, nausea, and dizziness.

How effective is it?

In clinical trials, the gammaCore Sapphire was shown to reduce the frequency of migraines by an average of 50% and the severity of migraines by an average of 30%.

How much does it cost?

The gammaCore Sapphire costs $1,995. The device is covered by some insurance plans.

How do I get one?

The gammaCore Sapphire is available by prescription only. Talk to your doctor to see if the device is right for you.