FDA grants Breakthrough Device Designation for Salvia BioElectronics migraine treatment


Salvia BioElectronics, Eindhoven, Netherlands, have received a Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its implantable neurostimulation system for the treatment of drug resistant chronic migraine.

Wim Pollet, chief medical officer of Salvia BioElectronics stated, “The FDA breakthrough device designation of our neurostimulation system reflects the recognition of the large unmet medical need of patients suffering from refractory chronic migraine, and the potential of Salvia’s bioelectronic foil technology to address this. We look forward to working closely with the FDA to expedite the review process to accelerate the development of our therapy.”

One in seven people suffer from migraines, and more than 5% of those with this condition suffer from chronic migraines, these subjects have on average 22 migraine days per month.

Only one in three of drug-refractory chronic migraine patients’ symptoms are helped with the newest generation of anti-migraine drugs, making neurostimulation a possible avenue for these patients.


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