The SAVI Dual™ is a central neuromodulation therapy device. It is the only such device approved by the US Food and Drug Administration (FDA) to help prevent and treat migraine. The SAVI Dual is made by eNeura, a medical technology company. The device was previously called eNeura® sTMS™ mini.1
SAVI Dual is a battery-powered handheld device. It can be used to prevent migraine or to treat an active attack. The device requires a prescription. It can be used by adults and children age 12 years and older.1,2
How does the SAVI Dual work?
The SAVI Dual is wireless, portable, and designed to be used whenever it is needed – inside or outside of the home. It uses magnetic stimulation to the head to provide a noninvasive, drug-free treatment for people with migraine.1,2
The device is placed at the back of the head to cradle the base of the skull. It should be held firmly against the head. Do not apply the device to other areas of the body. Treatment starts with the push of a button.1,2
Once the button is pushed, the device delivers a brief, single pulse of magnetic energy to the back of the head. This magnetic pulse passes through the head without any pain. This creates a brief electrical current in the brain which helps to stop or reduce the effects of migraine. This is also referred to as single pulse transcranial magnetic stimulation (STMS).2
Studies have shown STMS to be a safe, noninvasive technology. STMS can interrupt brain hyperactivity linked to migraine pain. This may result in a decrease in pain. For years this kind of treatment was only available in the doctor’s office. Now, thanks to advances in technology, smaller, user-friendly portable devices are available.1-3
What are the possible side effects?
Neuromodulation devices are a valuable option for people who are sensitive to the side effects of migraine drugs. These devices are also useful for those who want a drug-free approach. Side effects can vary depending on the specific device you are using.1-3
The most common side effects of the SAVI Dual include:2
- Tenderness at the spot where the device was held against the head
- Muscle spasm
- Minor dizziness
- Nausea or vomiting
- Headache and migraine
The SAVI Dual should not be used by people who:2
- Are pregnant
- Use medicines such as tricyclic antidepressants, neuroleptic agents, or drugs that lower the risk of seizure
- Have epilepsy, a history of seizures, or a history of stroke
- Have head trauma or a head injury
Metals and conductive materials can be affected by a magnetic field. So you also should not use SAVI Dual if you have:2
- Certain metals, conductive materials, or metal-containing implants in your head, neck, or upper body
- Implanted medical devices, such as a pacemaker, vagus stimulator, shunts, stents, cardioverter defibrillator, hearing aid implant, and many more
- Metallic implants such as a stent, bone plate, or screw
Improper use of the SAVI Dual can result in serious or life-threatening medical conditions. When using the device, stay at least 2 feet away from other people and keep away from metal and other electronic devices.2
These are not all the possible side effects of SAVI Dual. Talk to your doctor about what to expect when using SAVI Dual. You also should call your doctor if you have any changes that concern you when using SAVI Dual.
Other things to know
The SAVI Dual also offers the SAVI Smart Diary™. This online migraine diary can help you:1
- Monitor symptoms and migraine patterns
- Track the progress and effectiveness of treatment
- Share information with your doctor
Clinical trials have shown STMS to be as effective as drugs used to treat migraine with fewer risks or side effects. But the effects of long-term use of STMS devices is not known.1-3
People using the SAVI Dual device reported:1,3
- Fewer days with headache
- Relief from migraine pain
- Shorter headaches
- Less use of migraine drugs
Every person experiences migraine differently. Using the SAVI Dual will vary based on your individual needs. Work with your doctor to determine how often to use the SAVI Dual to prevent migraine attacks.1
Before beginning treatment for migraine, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you take. This includes over-the-counter drugs.
For more information, read more about the SAVI Dual.
