Nerivio® is a smartphone-controlled electroceutical device developed by Theranica Bioelectronics for the acute treatment of episodic or chronic migraine in adolescents.
The unit provides safe and effective relief from migraine pain without any side effects, which are typically seen in the use of therapeutic drugs.
The device received De Novo approval from the US Food and Drug Administration (FDA) for clinical use in May 2019. The FDA classified the device as a distal transcutaneous electrical stimulator for the treatment of acute migraine.
In September 2020, Nerivio received a CE mark under the new medical device regulation (MDR) European standard for acute migraine treatment.
In January 2021, the FDA expanded the device’s indication to include the acute treatment of episodic or chronic migraine in persons aged 12 years and older.
Nerivio can be accessed from any licenced healthcare professional, including telemedicine systems such as Cove and UpScript, with a prescription. It can also be delivered directly to the patient’s home.
Nerivio is available to veterans through a Federal Supply Schedule (FSS) agreement signed between Theranica and the United States Department of Veterans Affairs in February 2021.
Nerivio design and features
Nerivio is a non-invasive, drug-free, easy-to-use electronic device powered by a non-rechargeable battery. The integrated device is worn on the upper arm and operates through a mobile application. It visually resembles a sports armband.
The device comprises an electronics case, firmware, mobile application software and the armband, which is equipped with electrodes covered with hydrogel.
The plastic electronics case contains an on/off switch and light-emitting diode (LED) indicator, while the mobile application software is installed and run on a smartphone or tablet. The software controls the device and allows data and records to be stored and received.
A Nerivio unit is effective for 12 treatments, after which it can be discarded and a new device given to refill the prescription.
Nerivio mechanism of operation
Nerivio transmits weak electrical pulses on the skin for 45 minutes at a time to produce transcutaneous electrical nerve stimulation, which generates conditioned pain modulation (CPM) and inhibits migraine pain.
Read more: Get to Know About Nerivio: A Device for Treatment of Migraine
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