SAVI Dual™ Migraine Therapy Instructions for Use 7
•Precaution: Keep the System away from other electronic devices that depend-on
(receive) or radiate (transmit) radio frequency energy, when it is powered on.
•The operation of the System may be impaired when operated near home devices such
as wireless network routers, mobile phones, cordless telephones and their base
stations and walkie-talkies. Keep the SAVI Dual device at least 2 feet (0.6 meter)from
these devices when it is powered on and in use.
•Keep credit cards, audio/video tapes, computers, computer disks, flash memory
sticks, cell phones, personal digital assistants (PDAs), MP3 players, headphones,
digital cameras, portable glucose meters and other electronic devices or electronic
storage media more than 2 feet (0.6 meter)away from the System when it is in use.
•Keep any loose metal objects such as eyeglasses, keys, coins, jewelry, watches and
hair clips more than 2 feet (0.6 meter)away from the System when it is in use.
•Keep wearable medical devices such as insulin pumps, medicinal pumps, monitors,
bone grow stimulators and Transcutaneous Electrical Nerve Stimulator (TENS) devices
more than 2 feet (0.6 meter)away from the System when it is in use.
•Safety and effectiveness have not been established in pregnant women and children
under the age of 12.
•Caution should be used for patients with suspected or diagnosed heart problems.
•The System is only intended to be serviced or maintained by the manufacturer. Do
not attempt to open the device.The warranty may be invalidated. If the device is
opened, contact eNeura at: +1 833.499.9300 option 1.
•Keep the System out of the reach of children.
•Side effects can include minor dizziness, nausea, vomiting, application site tenderness,
muscle spasm, headache and migraine.
•Special precautions regarding Electromagnetic Compatibility (EMC) are required when
installing and using the System. Portable and mobile communications devices can
affect proper operation of the System. See “EMC Compliance and Warning
Statement” section of the Instructions for Use for more information.
Clinical Trial and Adverse Reactions
eNeura completed a clinical study in Headache Centers in the United States designed to support safety and
effectiveness of the device for the acute treatment and prophylaxis of migraine headache. Baseline medication
and symptoms were recorded for 28 days via patient diary. Subjects were instructed to use the device daily
(morning and evening) and for the acute treatment of attacks for three months with no change in preventive
medication. Study results showed statistically significant reduction in migraine headache days of 2.8 days from a
baseline mean of 9.1 days. Forty-six percent of the patients saw at least a 50% reduction in headache days
(responder rate). Reduction in acute medication was 2.9 days. A statistically significant improvement in quality of
life was reported. Six patients reported using prophylactic medications at baseline (2.8%), of these, 5 were using
topiramate and propranolol.
The efficacy of the eNeura device for prophylactic treatment is based on the result of an open label study. In open
label studies, bias may affect the result. Additionally, open-label studies may introduce placebo rates of 10-25%.
This is consistent with placebo rates reported in Randomized Controlled studies for migraine prevention.*
For further information about the clinical trial and any adverse reaction, please contact eNeura at 1-833-499-9300,
option 1 or consult your prescribing physician.
*Macedo A, Banos JE, Farre M. Placebo response in the prophylaxis of migraine: a meta-analysis. Eur J Pain 2008;
12;68-75
