FDA Approves Hi Tech Headband That Prevents Migraines

CEFALY

The Cefaly Headband That Prevents Migraines (1)

Engineers and pharmacists at STX-Med from Belgium have come up with a sophisticated electronic device that excites precisely the sensitive nerve cells to treat pain and motor neurons to obtain muscle contraction or treat muscle spasms. Known as the Cefaly, it has now been approved for sale in the US by the FDA. The device is already in usage among migraineurs in France, Canada, Australia and elsewhere. This external headband that offers neuro-stimulation is worn in particular to treat both migraines and tension headaches. (2)

The Cefaly is a battery-powered headband that emits electric currents to stimulate the nerves that are involved in migraine episodes. Tests on 67 patients have shown that this device reduces not only the total number of migraine attacks per month but also decreases the intensity of an attack.

The device is based on TENS (or Transcutaneous Electrical Nerve Stimulation) technology that has been studied in the medical circles for over four decades. The usage of TENS techniques is however, contraindicated under certain situations. (3)

The Cefaly device is meant to be administered on migraine patients and those with joint pains who are 18 years and older and for no longer than 20 minutes a day. The medical device is both CE and ISO certified for safety and performance as well as effectiveness.

It is believed to be 25% more effective than any other migraine management options available through prescription and is also effective in conditions such as insomnia and anxiety.

About 53 percent of 2,313 patients in a separate study said they were satisfied with the device and willing to purchase it for future use. (4)

For details of the study and a word from the doctors and developers, WATCH VIDEO: Migraine Relief Using New FDA-Approved Portable TENS Device ; Liberty Voice; Web March 2014; http://guardianlv.com/2014/03/migraine-relief-using-new-fda-approved-portable-tens-device/

SOURCES

  1. Image Credits: Cefaly Drug-Free Migraine Pain Relief; Cefaly; Web March 2014; http://www.cefaly.ca/
  2. FDA Approves Electric Headband to Prevent Migraine; ABC News; Web March 2014; http://abcnews.go.com/Business/wireStory/fda-approves-electric-headband-prevent-migraine-22866209
  3. FDA approves electric headband that prevents migraines; MedCity News; Web March 2014; http://medcitynews.com/2014/03/fda-approves-electric-headband-prevents-migraines/#ixzz2vj7F2HGq
  4. FDA Approves Electric Headband To Prevent Migraine; NPR; Web March 2014; http://www.npr.org/templates/story/story.php?storyId=289099411

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Cerena TMS Okayed For Sale On Prescription By FDA

fajb_magnet_for_headaches_01_dec2013

 

eNeura Therapeutics’ Transcranial Magnetic Stimulator (TMS) Now Available To Migraineurs With Aura (1)

US Food and Drug Administration (FDA) has allowed the marketing and sale on prescription eNeura Therapeutics device for the treatment and management of migraines. It has proved to be beneficial in pain mitigation for those whose migraine episodes are preceded by aura. Prior to awarding of approval, the FDA studied both at pre-market data as well as results of clinical trials of the device on migraineurs with aura. (2)

The device is essentially a transcranial magnetic stimulator (TMS). The Cerena TMS is to be held against the back of the migraineur’s head and turned on by the push of a button. The device releases short pulses of magnetic waves to stimulate the occipital cortex of the migraineur’s brain which in turns either ceases pain or reduces the intensity of pain. The device does not relive any other symptom associated with migraines such as photo or sound sensitivity, nausea etc. (3)

Though classified as a low-moderate risk device, it is not to be used by those suffering from epilepsy and not more than once every 24 hours even by those who are prescribed the use of the TMS. The transcranial magnetic stimulator is not recommended for those patients who have any type of implants especially magnetic metals in the head, neck or upper body, pacemakers, deep brain stimulators etc.

Randomized controlled trials on some 201 patients showed that approximately 38% of those using the TMS device were free of any pain in two hours after administration compared to 17% of controls.

SOURCE

  1. Image Credit: The Transcranial Magnetic Stimulator by eNeura Therapeutics ; Electronicproducts.com; Web December 2013; http://www.electronicproducts.com/Passive_Components/Magnetics_Inductors_Transformers/FDA_approves_pulsating_magnetic_device_to_help_ease_headaches.aspx
  2. First device to treat migraine wins FDA approval; MedicalNewsToday.com; Web December 2013; http://www.medicalnewstoday.com/articles/270233.php
  3. FDA approves pulsating magnetic device to help ease headaches; Hearst Electronic Prodcuts; Web December 2013; http://www.electronicproducts.com/Passive_Components/Magnetics_Inductors_Transformers/FDA_approves_pulsating_magnetic_device_to_help_ease_headaches.aspx

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