FDA approves updated version of SNM device for OAB

The FDA has approved the third-generation version of Axonics Modulation Technologies rechargeable implantable neurostimulator (INS) for the treatment of patients with urinary and bladder dysfunction.¹

The INS device was launched commercially in the United States in November 2019. A second-generation version approved in April 2020 prolonged the device’s recharge interval. The third-generation model upgrades the software embedded in the device and enhances the functionality of the remote control, which is used by patients to monitor their stimulation level and the need to recharge the stimulator.

“This is another significant upgrade we have made to the Axonics System, underscoring our commitment to continuous innovation that enhances the patient experience. While our long-lived INS device is as close to a 'set it and forget it' therapy, the new features will benefit physician practices in which patients have to travel long distances should they require therapy adjustments. We are confident that continuing to ensure excellent patient experiences will drive significant market expansion in the years ahead and result in SNM therapy becoming the preferred solution for urinary and bowel dysfunction,” Raymond W. Cohen, CEO of Axonics, stated in a press release.

Efficacy of INS device

Efficacy data for the Axonics rechargeable sacral neuromodulation (SNM) system were presented during the 2020 American Urological Association Virtual Experience.² The results were 1-year follow-up data from the pivotal trial that led to the initial approval of the device. The findings showed that SNM with the Axonics INS provided highly safe and durably effective treatment for urinary urgency incontinence (UUI).

Reduction in UUI episodes observed at the study’s primary end point at 6 months were sustained through 1 year, and the safety profile of SNM with the rechargeable device was consistent with SNM experience reported in the literature. It was also noted that patients had clinically significant improvements in quality of life (QoL) and a high level of satisfaction with the device.

The single-arm trial enrolled 129 patients at 19 centers in the United States and western Europe. Subjects were eligible for inclusion if they had 4 or more UUI episodes in a 3-day diary, including 1 or more episode per day. Individuals with more than a minimal level of stress incontinence, anatomic urinary tract obstruction, or an underlying neurological condition were excluded.

The trial’s participants ranged in age from 21 to 86 years (mean, 59) and were almost entirely women (98%). Mean UUI episodes per day at baseline was 5.6. The primary end point for the study assessed the rate of therapy responders at 6 months. Ninety percent of women, defined as participants achieving a 50% or greater reduction in UUI episodes per 3 days, achieved the end point. The therapy responder rate was 89% at 1 year.

At 6 months, it had decreased to 1.3 episodes per day and it was 1.4 at 1 year. Furthermore, more than three-fourths of patients had at least a 75% reduction in daily UUI episodes at 1 year, and the remaining participants achieved at least a 50% reduction.

Quality of life was evaluated using a validated questionnaire (International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module). At 1 year, changes from baseline in the total score and in scores for individual domains (concern, coping, sleep, and social) ranged from 22 to 34. All of the QoL improvements were statistically significant and far exceeded the minimum 10-point change that is considered clinically significant.

At 1 year, 93% of patients said they were satisfied with the therapy, and 92% said they would undergo the therapy again with the same expected results. Questions pertaining to the charging of the device showed that it was considered easy by 89% of participants, and 96% rated the frequency and duration of charging as acceptable. Ninety-five percent of participants reported recharging the device no more than once a week, and 86% reported that the total charge time was 60 minutes or less.

There were few adverse events (AEs) in the series and no serious device-related AEs. The most common AE was uncomfortable change in sensation or magnitude of stimulation (5%).

References

1. Axonics® Receives FDA Approval for Third-Generation Implantable Neurostimulator. Published online February 16, 2021. Accessed February 22, 2021. https://bit.ly/3uhPIyJ.

2. Long Term Clinical Results on Treatment of Urinary Urgency Incontinence with the Axonics Rechargeable Sacral Neuromodulation System. Presented at: 2020 AUA Virtual Experience. Abstract PD27-12.