Neuromodulation device Relivion gets FDA clearance to help patients with major depression who don’t benefit from antidepressant medications

by

Neu­rolief wins FDA break­through nod for wear­able neu­ro­mod for depres­sion (Mass Device):

Neu­rolief announced today that it received FDA break­through device des­ig­na­tion for its Reliv­ion DP sys­tem for treat­ing major depression.

Reliv­ion is a wear­able, non-inva­sive, mul­ti-chan­nel brain neu­ro­mod­u­la­tion device designed as an adjunc­tive treat­ment to phar­ma­ceu­ti­cal man­age­ment of major depres­sive dis­or­der (MDD) in adults who haven’t expe­ri­enced sat­is­fac­to­ry improve­ment from anti­de­pres­sant med­ica­tions, accord­ing to a news release.

Netanya, Israel-based Neurolief’s Reliv­ion DP is a head­set-like device placed on the head to stim­u­late the release of neu­ro­trans­mit­ters in the brain­stem and mod­u­late brain net­works asso­ci­at­ed with con­trol of mood. The device trans­fers mild elec­tri­cal puls­es to the brain­stem via six branch­es of the occip­i­tal and trigem­i­nal nerves and can be used in tan­dem with its smart­phone app and a cloud data­base that allows for remote mon­i­tor­ing and care.

From the press release:

“As we find our­selves in the midst of a large and grow­ing glob­al men­tal health cri­sis, more and more patients are in need of effec­tive options that lack the short and long-term side effects we see with tra­di­tion­al treat­ments,” said Lin­da Car­pen­ter, MD, a Pro­fes­sor of Psy­chi­a­try and Human Behav­ior in the War­ren Alpert Med­ical School at Brown Uni­ver­si­ty. As per Dr. Car­pen­ter, “Based on its effi­ca­cy and safe­ty pro­file, Reliv­ionDP® could be the answer for the approx­i­mate­ly 40% of patients with depres­sion who do not respond to stan­dard med­ica­tion and psy­chother­a­py treat­ments. The fact that it’s also wear­able, allows for a per­son­al­ized lev­el of treat­ment, and has remote mon­i­tor­ing capa­bil­i­ties makes this an extreme­ly attrac­tive option for patients with major depression.”

The Break­through Devices Pro­gram was estab­lished by the FDA to pro­vide patients and health­care providers with time­ly access to trans­for­ma­tive med­ical devices by speed­ing the devel­op­ment, assess­ment, and review of inno­v­a­tive med­ical devices.

News in Context: