The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. The R20 neurostimulator uses the same small 5cc form factor as the previous-generation R15. It pairs with the same tined lead and intuitive patient remote control. It also features enhanced programming capabilities with expanded MRI labeling.
R20 has a functional life in the body of at least 20 years and reduces charging frequency to every 6-10 months for just one hour.
Axonics won FDA approval for this generation of the R20 in January 2023. It then picked up CE mark for the R20 in March of this year.
The Irvine, California-based company kicked off commercial activities in Australia in March 2023. It won regulatory approval to market its F15 recharge-free SNM system in the country a few months ago as well. The company also markets its Bulkamid hydrogel for female stress urinary incontinence in Australia.
Axonics plans to begin sales of the R20 system to Australian customers in November.
“We are delighted to receive regulatory approval for our latest rechargeable SNM system in Australia,” said Raymond W. Cohen, CEO. “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.”
