Is this FDA approved?

The implantable neurostimulator devices that we use today are manufactured by St. Jude Medical, Boston Scientific and Medtronic Corp and have been fully FDA approved devices for over 40 years for chronic back and neck pain.

And, after over 2 decades of use, the neurostimulator implant procedures that we use are accepted as a standard of care across the medical community, as an “off label” application for chronic head pain.

Further, Medicare and most commercial and national carriers now approve implantable peripheral neurostimulation for various types of chronic head pain and/or headaches. For example, Medicare’s national policy indeed now fully approves implantable neurostimulation for treatment resistant chronic migraines.

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