Axonics R20 Rechargeable Sacral Neuromodulation System Nabs CE Mark

Axonics today announced its R20 rechargeable sacral neuromodulation (SNM) system has received CE Mark approval for use in adults with overactive bladder and/or fecal incontinence.  The implant can last in the body for at least 20 years and reduces how frequently the device needs to be recharged to once every six to 10 months for one hour.

R20 uses a small 5cc form factor — the same as its R15 iteration and is also paired with the same tined lead and patient remote control. The tined lead is a helical-tined design to mitigate lead migration and has visible and radiopaque markers for implantation. The remote control is recharge free, pocket sized, indicates when the implant needs to be recharged, checks if the system is ready for fully body MRI without requiring an office visit, and adjusts therapy levels for both trial and permanent therapies. The charging system wirelessly charges the device through the skin on a stretchable belt that goes around the waist.

The R20, compared to the R15, provides physicians and patients with enhanced programming capabilities and expanded MRI labeling, according to Axonics.

The company said it expects to start selling the implant in Europe by mid-April. R20 first received approval from Health Canada in December 2022, and then FDA approval in January 2023.

“Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said Raymond W. Cohen, chief executive officer, in the press release announcing the CE Mark. “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 U.S. and international markets in the years ahead.”