FDA Approves Medical Device for Prevention and Treatment of Migraine

A recently FDA approved, non-invasive, drug-free, electrode-based Cefaly® headband device is now available in the U.S. for migraineurs.

Neurologist Pierre Rigaux, CEO of Cefaly Technology, and a member of the inventor’s team, credits Belgian Professor Dr. Jean Schoenen and electronics engineer, Pierre-Yves Muller for conception and development of Cefaly® that is manufactured by STX-Med in Herstal, Liege, Belgium.

This medical device operates with a transcutaneous electrical nerve stimulation (TENS) unit. TENS units are not a new concept, but their focus and pinpoint concentration have been improved.

Cefaly’s self-adhering electrode headband model offers the promise of a better quality-of-life and more normal day-to-day living for those who suffer from migraines. It’s safe without major side effects, and with supervision, even those as young as eight may use it.

The (PREvention of MIgraine with CEfaly®) PREMICE study showed a 71% treatment satisfaction rate with the reduction of medication of almost 75%. [1] By comparison, the placebo group showed the reduction of medication use to be 37%. A clinical trial with 2,313 subjects in France and Belgium found a 53% rate of satisfaction. [2]

Cefaly® specifically stimulates endorphin-production that prevents the invasion of pain stimuli. With a higher level of endorphins, the trigger threshold of migraine is raised that lessens the vulnerability of a migraineur’s hyperexcitable nervous system. [3]

 

CefalyheadbandYouTube video on instructions for operation of Cefaly®:
https://www.youtube.com/watch?v=Br8kdUpQyVo

The current indications for using Cefaly® are: migraine with and without aura, ophthalmic, and menstrual migraine, anterior and posterior tension headaches, and Arnold Chiari malformation or occipital neuralgia. [4]

According to media contact for Cefaly, Maria Coder, “Cefaly® is a prescription only product that is intended for 20 minute a day for reduction of attacks of migraine. It may be purchased online at www.Cefaly.us. The unit will retail for $295.00 plus $29.00 for shipping. The price of a three pack of electrodes is $25.00. (Each electrode will last for up to 20 uses.)”

For instructions on using Cefaly®: http://www.cefaly.ca/site/userguide

For additional information to frequently asked questions and published clinical trials:

 

  1. CefalyFrequently Asked Questions
  2. Piquet, et al. Sedative_BMC Neurology_2011;11;135

 

Questions:

  1. What do you currently use to aid your patients in the reduction of their migraine headaches?
  2. Would you consider prescribing the Cefaly® device for possible prevention of migraines?   Yes  No
  3. Would you consider using Cefaly® for treatment of migraines that might lessen their severity?   Yes  No

 

References

  1. Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013 Feb 19;80(8):697-704.
  2. Magis D, Sava S, d’Elia TS, Baschi R, Schoenen J. Safety and patients’ satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013 Dec 1;14:95.
  3. Cefaly® website. Cefaly drug-free migraine pain relief. 2014. http://www.cefaly.ca/#howitworks. Accessed March 14, 2014.
  4. Cefaly Technology© website. The current indications for using Cefaly. http://www.cefaly.com/en/indications. Accessed March 17, 2014.