Axonics has announced that the Axonics R20 rechargeable sacral neuromodulation (SNM) system has received CE-mark approval.
Axonics expects to commence sales of the R20 to European customers in mid-April, as per a company press release. The R20 also received approval from the US Food and Drug Administration (FDA) in January 2023 and from Health Canada in December 2022.
The release notes that the R20 neurostimulator is labelled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to once every 6–10 months for only one hour.
The implant utilises the same small 5cc form factor as the previous generation (Axonics R15) and is paired with the same tined lead and intuitive, easy to use patient remote control. The R20 also provides physicians and their patients with enhanced programming capabilities and expanded magnetic resonance imaging (MRI) labelling, the release adds.
“Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said Raymond W Cohen, chief executive officer of Axonics. “Patients with overactive bladder tell us that, first and foremost, they value efficacy and a long-lived solution to address their chronic condition. The R20 represents another significant breakthrough for rechargeable neuromodulation devices and underscores Axonics’ commitment to continuous innovation. We are confident that our keen focus on the incontinence patient population has the potential to drive significant market expansion in both the USA and international markets in the years ahead.”
