The approval comes after a study of the effectiveness of the migraine device.
The U.S. Food and Drug Administration announced today that the Theranica therapeutic device, Nerivio, has been launched to the market for an extended signal for the acute treatment of episodic or chronic migraine in patients at least 12 years of age.
Nerivio is worn on the upper arm for 45 minutes and uses Peripheral Electrical Neuromodulation to activate the Brain Positioning Modeling apparatus to treat pain and associated migraine symptoms.
“The availability of this drug-free migraine treatment for the teenage migraine community could have a positive impact on patient compliance,” said Jennifer McVige, MD, a board-certified physician in pediatric neurology, adult and pediatric headache and neuroimaging at DENT Neurologic Institute, in its statement. “N Nerivio is an effective smartphone-controlled technical solution that can be obscurely worn and is a perfect design for teens who may be unfortunate enough to have migraine attacks. ”
The eviction follows an investigation published in the journal A sore head. The results of the study showed that 71% of teenage participants who used the device experienced pain relief after two hours while 35% were completely pain-free. In 90% of cases, pain relief and pain relief were maintained for 24 hours. The majority of patients (69%) experienced an improvement in their ability to function, meaning that they were able to do homework and perform normal activities at two hours.
There were no adverse events associated with the use of the digital therapy.
Nerivio is available by order from an approved healthcare provider and is good for 12 units before being recycled. Patients can then refill the prescription with a new device. It
“This new brand is an incredible step in our dedicated effort to serve the migraine community as a whole,” said Theranica CEO and co-founder Alon Ironi.