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