Axonics R20 sacral neuromodulation system now available in Europe

The Axonics fourth-generation rechargeable R20 sacral neuromodulation (SNM) system has been granted Conformité Européene (CE) Mark approval, making the technology available for the treatment of European patients with overactive bladder (OAB) and/or fecal incontinence, according to a news release from Axonics, the developer of the device, in a news release.¹

Rhe R20 system also received FDA approval in January 2023 and Health Canada approval in December 2022.

“Delivering a superior patient experience has been at the forefront of our SNM development efforts. Patients with overactive bladder tell us that first and foremost, they value efficacy and a long-lived solution to address their chronic condition,” said Raymond W. Cohen, CEO of Axonics, in the news release.¹ “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.”

According to the news release, commercial sales of the R20 system in Europe are expected to begin in mid-April.

Once implanted in patients, the SNM device requires to be recharged once every 6 to 10 months for 1 hour. The functional life of the system in the body is labeled for at least 20 years. This generation of the technology utilizes the same small 5cc form factor as the previous iteration, Axonics R15, and is also paired with the same tined lead and patient remote control. Additionally, the R20 system includes enhanced programming capabilities and expanded MRI labeling compared with the previous generation.

In addition to the CE mark approval, the R20 system also received FDA approval in January 2023² and Health Canada approval in December 2022.³

Data on Axonics Therapy

The safety and efficacy of Axonics Therapy was demonstrated in the ARTISAN-SNM trial (NCT03327948) in patients with urinary dysfunction, as well as in the RELAX-OAB trial (NCT02620410) in patients with OAB.

In total, the prospective ARTISAN-SNM study enrolled 129 patients with urge urinary incontinence (UUI) across 19 centers in the US and Europe.⁴

Overall, data from the trial showed sustained safety and efficacy of the therapy, with 93% of participants marked as responders to therapy at 2-year follow-up. Among the responders, 82% achieved a 75% or greater reduction in UUI episodes, and 37% were completely dry. Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2-year follow-up.

Regarding safety, no unanticipated or serious adverse events (AEs) were reported.

The safety and efficacy of Axonics therapy was also assessed in the RELAX-OAB trial, which enrolled 51 patients with OAB across 7 centers in Europe.⁵

Results from the study also demonstrated sustained efficacy and safety with the treatment. At 2-year follow-up, 90% of therapy responders continued to show response to therapy based on voiding diary criteria. Among the test responders with urinary incontinence, 88% were responders at 2-year follow-up and 28% were completely dry. In total, 93% of patients reported a satisfactory experience with the therapy.

No unanticipated or serious AEs were reported.

References

1. Axonics receives CE Mark Approval for fourth-generation rechargeable sacral neuromodulation system. News release. Axonics, Inc. March 14, 2024. Accessed March 19, 2024. https://ir.axonics.com/news-releases/news-release-details/axonics-receives-ce-mark-approval-fourth-generation-rechargeable

2. Axonics receives FDA approval for fourth-generation rechargeable sacral neuromodulation system. News release. Axonics, Inc. January 31, 2023. Accessed March 19, 2024. https://ir.axonics.com/news-releases/news-release-details/axonics-receives-fda-approval-fourth-generation-rechargeable

3. Axonics receives Health Canada approval for fourth-generation rechargeable sacral neuromodulation system. News release. December 13, 2022. Accessed March 19, 2024. https://ir.axonics.com/news-releases/news-release-details/axonics-receives-health-canada-approval-fourth-generation#:~:text=The%20newly%20approved%20Axonics%20R20,months%20for%20only%20one%20hour.

4. Pezzella A, McCrery R, Lane F, et al. Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. Neurourol Urodyn. 2021;40(2):714-721. doi:10.1002/nau.24615

5. Blok B, Van Kerrebroeck P, de Wachter S, et al. Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. Neurourol Urodyn. 2020;39(4):1108-1114. doi:10.1002/nau.24317