The Essential Guide To Medical Devices For Migraine

CEFALY^®

CEFALY is an FDA-cleared medical device that targets the main pathway for migraine pain: the trigeminal nerve (the largest cranial nerve).

To use CEFALY, attach a gel electrode to clean skin on the forehead, just above the eyebrows. CEFALY attaches magnetically to the electrode. The 60-minute ACUTE setting, used at the first sign of a migraine attack, is clinically proven to relieve migraine pain. This setting uses high-frequency eTNS to block pain signals in the trigeminal nerve.

With compliant daily use, the 20-minute PREVENT setting is clinically proven to help reduce migraine frequency. This setting uses low-frequency signals to gradually desensitize the trigeminal nerve.

CEFALY is easy to use, with a single treatment activation button and an optional companion app, the CeCe Migraine Management app. CEFALY is safe: side effects have been demonstrated to be minor and fully reversible with cessation of device use. Most importantly, CEFALY is yours to keep. Unlike other medical devices that must be refilled or replaced, CEFALY is designed to last, with a 3-year limited warranty.

• Prescription required for CEFALY? No
• Is the device yours to keep? Yes
• FDA cleared? Yes

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Nerivio^® (REN wearable armband device)

Nerivio is a remote electrical neuromodulation (REN) device for migraine that’s placed on the upper arm at the onset of migraine symptoms and worn for 45 minutes. Each Nerivio unit works for 18 treatments, and then the prescription is refilled with a new device.

How does Nerivio work? It stimulates small nerves that send messages to a pain regulation center in the brainstem, triggering it to release neurotransmitters that relieve pain. Its 45-minute acute program should be used as often as needed to relieve migraine pain, and its 45-minute preventative program should be used every other day.

• Prescription required for Nerivio? Yes, prescription must be obtained and refilled
• Is the device yours to keep? No, it’s disposable
• FDA cleared? Yes

gammaCore Sapphire^TM (vagus nerve stimulator)

gammaCore Sapphire is a non-invasive vagus nerve stimulation (nVNS) device intended to treat and prevent migraine and cluster headaches.

How does gammaCore work? When you hold the gammaCore device against the neck, it provides a mild electrical stimulation to the vagus nerve. By stimulating the vagus nerve, pain signals causing migraine attacks can be blocked, helping to relieve pain and preventing future attacks before they happen.

Conductive gel must be applied to the gammaCore device before a treatment. A “deep and strong vibration” is felt inside the neck during use, according to the manufacturer. The user can adjust the intensity. A special, prescription-only refill card, sent each month, is required to keep using your device.

To prevent migraine, gammaCore Sapphire is used for three treatments every day (morning, mid-day and night). Each treatment is two consecutive 2-minute sessions. For acute migraine pain relief, two consecutive 2-minute stimulations are applied at the onset of pain or symptoms, with up to two additional treatments after that.

• Prescription required for gammaCore? Yes, prescription must be obtained and refilled
• Is the device yours to keep? Yes, but requires prescription refills
• FDA cleared? Yes

Relivion^® (dual-nerve headband device)

Relivion is a headband-like neuromodulation device for migraine pain relief only. It goes around the head and stimulates the trigeminal nerve (through the forehead) and the occipital nerve (in the back of the head).

How does Relivion work? The user attaches a set of electrodes to the headband and sprays them with water. Then, the user must fit the headband tightly on their head in the right position. The device will give you an error message if the placement’s not quite right. Treatments typically last between 20-60 minutes. Relivion requires a minimum of 8-12 weeks to see results.

Patients must begin by paying $150 for a 60-day Relivion Therapy Program will be $150. After this trial period, they can purchase the device starting at $650.

• Prescription required for Relivion? Yes
• Is the device yours to keep? Yes
• FDA cleared? Yes

SAVI Dual (handheld sTMS device)

SAVI Dual uses single-pulse transcranial magnetic stimulation (sTMS) technology. Used daily on the back of the head, it delivers a pulse of magnetic energy to the outer layers of the brain to quiet the electrical impulses that initiate a migraine attack.

For migraine prevention, the sTMS device is intended to be used twice per day — four pulses in a 15-minute session in the morning, and the same in the evening. Sessions of three sequential pulses, with 15-minute breaks in between, are used for acute migraine treatment.

SAVI Dual requires a $395 monthly prescription fee.

• Prescription required for SAVI Dual? Yes
• Is the device yours to keep? No; ongoing subscription required
• FDA cleared? Yes

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CEFALY vs. other migraine devices

Migraine is a complex disorder that doesn’t look the same in everybody. Medication may not work for everyone, and not everyone responds to treatments the same way. That’s why it’s important for you to find a treatment approach that works for you.

At CEFALY, we believe that everybody living with migraine deserves access to a drug-free treatment that works. You don’t need a prescription to get CEFALY. And unlike other devices, we don’t charge you fees or require refills to use the device. Your only ongoing cost is replacement electrodes, and each electrode can be used many times. CEFALY is the simpler, smarter, most affordable choice for treating migraine with neuromodulation!

Discover why CEFALY is the #1 FDA-cleared migraine treatment device that’s available without a prescription. Try CEFALY today.