• 21 January 2020
    Axonics® Announces FDA Approval of Enhanced Neurostimulator Programmer

    Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable Sacral Neuromodulation (SNM) devices for the treatment of bladder and bowel dysfunction, today announced U.S. Food & Drug Administration (“FDA”) approval of an enhanced, second-generation Programmer for its r-SNM® System under a premarket approval (“PMA”) application supplement.

    The new Programmer is used to program the Axonics external trial neurostimulator as well as the implantable neurostimulator in both the procedure and post-operative environments.

    The Programmer is a custom-made tablet with a color touchscreen and an easy-to-use graphical interface and expands on its user-friendly capabilities by streamlining and simplifying the patient programming process.

    The Programmer offers, among other things:

    • A predictive programming algorithm that translates intra-operative responses and suggests how to program the patient for optimum therapy thereby reducing the need to adjust therapy post-implant

    •A fully wireless system that reduces time during surgery and simplifies post-implant device programming

    • Tools that facilitate lead placement and programming

    • Exportable reports on SNM therapy performance and device usage for both temporary external trials and permanent implants

    Raymond W. Cohen, CEO of Axonics, commented, “Axonics is committed to further enhancing our SNM product offerings to ensure physicians have the latest technology available to treat this underserved patient population and develop what we believe is a multi-billion-dollar market opportunity. These innovations will further enable clinicians using the Axonics rSNM System to identify optimal lead placement during the implant procedure and personalize therapy for each patient. FDA approval of the second-generation Programmer is part of an anticipated cadence of product enhancements in our robust product pipeline.”

    The long-lived, rechargeable, full-body MRI-compatible Axonics r-SNM System has obtained U.S. FDA approval, European CE Mark approval, Health Canada approval, and Australian Therapeutic Goods Administration approval for the treatment of overactive bladder, urinary retention and fecal incontinence. Axonics launched commercially in the United States following FDA approval in late 2019.