Axonics Brings Updated Neurostim Implant to the U.S. Following FDA Green Light

Axonics has big plans to bring its updated neuromodulation implant for treating incontinence into the U.S. following a pivotal Canadian approval. Roughly a half a year after its initial submission to the FDA, the fourth-generation R20 device has now earned approval for use in treating bladder and bowel dysfunction.

Axonics Chief Executive Officer Raymond Cohen sagely predicted the approval would come through around this time, and has accordingly set up a rollout in the U.S. that is due to commence in March. However, he indicated the launch would be “more limited” thanks to Axonics’ already burgeoning share of the saturated neurostimulation market in the U.S. A study of the company’s neurostimulation therapy conducted in 2020 found that 30 out of 51 individuals with overactive bladder had positive responses to the treatment within a month of implant installation.

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Requiring only one hour of charging once every six to ten months, as opposed to previous generations needing monthly recharges, the R20 is meant to stay implanted for at least two decades. The charging process occurs through the skin of the lower back with a wireless power bank that is positioned using an adhesive carrier or stretchy belt. Every unit is paired with a keychain-sized wireless controller that gives users control over the intensity of their neurostimulation as well as provides advanced warnings about upcoming recharges.