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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

Benzinga · 01/21/2020 11:00

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