September 2021

FDA Grants Breakthrough Device Designation for Amputee Pain Block System

Neuros Medical, Willoughby Hills, OH, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel high-frequency nerve block system as an aid in the management of chronic intractable pain of the lower limb of adult amputees. The Neuros Altius System consists of an implantable generator, about the size of a pacemaker, with an integrated rechargeable battery, cuff electrode, and external devices (clinician programming wand, patient controller, and charger). The generator sends a high-frequency signal to the electrode, which is placed around the peripheral nerve, thus blocking the pain signals.

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