Neurolief today announced that it received FDA approval for its Relivion noninvasive neuromodulation system to treat migraines.
The noninvasive, multi-channel brain neuromodulation system is designed to treat acute migraines from home. It is a headset that administers personalized care to patients by delivering stimulation to six branches of the occipital and trigeminal nerves through three adaptive output channels. The output channels allow for the release of neurotransmitters in the brainstem and modulation of brain networks associated with control of pain.
“The FDA clearance of the Relivion noninvasive device is an important event for those suffering from migraines, as it is the only neuromodulation technology thus far that has demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within 2 hours after treatment, in a sham-controlled clinical trial,” principal investigator on the pivotal international trial Stewart Tepper said in a news release. “Patients will now have access to a highly effective, easy-to-use, noninvasive, and drug-free therapeutic option that will help them regain control of their lives.”
The FDA clearance is based on the results from a multi-center, prospective, randomized, double-blind, placebo-controlled clinical study. In the study, 46% of patients in the active group were pain free, compared to only 11.8% of patients in the control group, according to the company. 75% of patients in the active group had complete freedom from the most bothersome symptoms (photophobia, photophobia or nausea) within two hours of treatment.
“This is a major milestone both for Neurolief and the migraine community. Relivion offers a new paradigm for doctors treating migraine patients, reducing the dependence on pharmaceutical products and invasive procedures while keeping doctors informed of the patient’s progress,” Neurolief chairperson Chris Richardson said in a news release. “It also demonstrates our commitment to becoming the leader in neuromodulation therapy, and allows a springboard to advance this technology in the future for other neurological and neuropsychiatric disorders.”