Medical Device Network

Axonics’ sacral neuromodulation device cleared in Australia

Axonics says that its device significantly reduces the user's need to recharge as it marks its second clearance in only a year in the market.

US Medical device giant Axonics has announced that it has secured market clearance from Australia’s Therapeutic Goods Administration (TGA) for its R20 rechargeable sacral neuromodulation (SNM) system designed to treat adults with overactive bladder and faecal incontinence.

Designed to last as long as 20 years in the user’s body, Axonic claims that its SNM system reduces how frequently a patient needs to recharge their implanted device to once every 6 to 10 months for only one hour. It also comes with additional programming options and expanded MRI labelling.

The announcement comes a year after the company moved to bring its SNM devices to the Australian market in May of 2023. In that time Axonics received regulatory approval from the TGA to market one other SNM device, its F15 recharge-free model. Now, the company says it plans to market its newest device beginning in November.

Raymond Cohen, CEO of Axonics, said: “We are delighted to receive regulatory approval for our latest rechargeable SNM system in Australia. Our mission-driven team remains committed to innovating, supporting our dedicated physician customers and their patients, and raising awareness of our best-in-class incontinence therapies.”

GlobalData’s Medical Devices Database details how the global market for neuromodulation devices is estimated to be worth $6.4bn by the end of this year. Of that SNM devices comprise approximately $1.05bn of that market. Australian market comprises approximately $2.8m with that figure expected to rise to $3.2m by the end of 2030.

The announcement comes after the company was able to clear its SNM devices before the US courts following a patent infringement trial that saw the company sued by Medtronic. The full jury trial before the California court found that Axonic’s r-SNM devices did not infringe on three other patents.

The announcement also comes amid a period of high scrutiny for neuromodulation devices across Australia after a series of research reports produced by the University of Sydney concluded that Spinal Cord Stimulation devices were neither safe nor effective when it comes to managing pain, seeing devices pulled from the market across the region.