FDA-Approved Migraine Device – CEFALY

Renowned for helping prevent migraine attacks, a new FDA clearance paves way for more CEFALY devices that can now stop a migraine in progress and prevent a future episode too.

CEFALY Technology announces today the release of two new U.S. Food and Drug Administration (FDA)-cleared migraine treatment devices. CEFALY®, already the first FDA-approved external trigeminal nerve stimulation (e-TNS) device for the prevention of migraine attacks, is now the only migraine device available for use during a migraine attack with or without aura.

“We are excited that we can now offer migraine patients several drug-free options in their migraine care,” said Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology, and a member of the team that invented the device. "Hemos desarrollado una manera de que los pacientes con migraña frenen y prevengan una migraña sin medicación y con casi ningún efecto secundario".

The new FDA-approval follows several clinical trials that demonstrated that one hour of e-TNS with the CEFALYy® device can relieve or stop the migraine headache. Los resultados del estudio controlado con placebo, aleatorizado, a doble ciego, acerca del tratamiento agudo de la migraña con estimulación externa del nervio trigémino se presentaron en un encuentro reciente de la International Headache Society. The findings showed that on average, the CEFALY® treatment reduced migraine pain by 65%. Además, el 32% de los pacientes no tuvieron dolor dentro del plazo de una hora.

Proprietary CEFALY® technology has been adapted to efficiently and safely address the different phases of migraines. Our Connected model brings together two treatment options in a singular device as well as a bluetooth-connected integration with our CeCe app, combining treatment options with tracking tools for an all inclusive treatment plan.

A pesar de estas diferencias, los dispositivos se administran de la misma manera: se coloca un dispositivo en la frente mediante una conexión magnética a un electrodo autoadhesivo, que luego envía microimpulsos precisos a través de la piel hacia las ramas superiores del nervio trigémino para aliviar el dolor de cabeza durante un ataque de migraña o para prevenir un ataque de migraña futuro.

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