FDA Approves Axionics’ Neurostimulator Programmer

After undergoing rigorous scrutiny by the FDA, Axionics has finally received clearance for its unique Sacral Neuromodulation (SNM) device. The device intends to provide an implantable and rechargeable method for the treatment of bladder and bowel dysfunction. The FDA announced approval today of a second-generation version of the enhanced neurostimulator programmer for the Axionics rSNM system. The programmer is used in conjunction with the external trial neurostimulator. It can also be utilized by the implantable neurostimulator in both the procedure as well as after the operation has completed.

Simplified Interface for a Complex Methodology

The programmer is based on familiar technology, and the interface is a custom-built tablet that offers an easy-to-understand GUI. The programmer can advise on the optimum therapy for a particular patient, reducing the need to adjust the treatment after the implant operation is complete. The wireless system allows for faster surgery time and programming the device post-op. Additionally, users of the system can export reports on therapy performance as well as usage of the device for both the external trial as well as permanent internal implants. The tablet also includes tools that doctors can use to aid them in developing custom programming for the implanted and external trial neurostimulators.

Widespread Acceptance

The FDA’s approval of the programmer comes on the heels of Axionics’ commencement of operations in late 2019. The company started commercially producing neurostimulators when the FDA approved its hardware. Along with the FDA, other international bodies such as Health Canada, European CE Mark, and the Australian Therapeutic Goods Administration have all passed the neurostimulators for use in patients that display overactive bladders or bowel incontinence. Axionics has taken the lead in commercializing the use of SNM devices to aid patients suffering from these conditions. Axionics’ is the first rechargeable SNM to enter the market in the US, as well as the first to achieve full-body MRI labeling.