European CE Mark approval has been granted to the second-generation version of Axonics r-SNM implantable neurostimulator (INS) and wireless patient remote control for the treatment of patients with bladder and bowel dysfunction.1
The second-generation update prolongs the device’s recharge interval to 1 hour each month. The CE Mark on the device allows it to be sold throughout the European Economic Area, which encompasses the EU as well as Iceland, Liechtenstein, and Norway.
“There has been a significant backlog of pending regulatory submissions in Europe due to Covid-19 and the transition to the new European Union Medical Device Regulation, which will become fully applicable later this month,” Rinda K. Sama, chief operating officer of Axonics, stated in a press release. “Despite the delay and investment of Axonics’ regulatory resources, we are committed to supporting our customers and delivering a superior therapy experience in all markets worldwide where Axonics has an established presence.”
In the United States, Axonics INS device was launched commercially in November 2019 and the second-generation version was approved by the FDA in April 2020. On February 22, 2021, the FDA approved the third-generation of the device, which is not yet approved in the EU.2
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.
Efficacy data for the Axonics rechargeable sacral neuromodulation (SNM) system were presented during the 2020 American Urological Association Virtual Experience.3 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 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.
1. Axonics® Announces CE Mark Approval for Implantable Sacral Neurostimulator that Significantly Extends Recharge Interval. Posted online May 18, 2021. Accessed May 19, 2021.https://bwnews.pr/3wiD7eH.
2. Axonics® Receives FDA Approval for Third-Generation Implantable Neurostimulator. Published online February 16, 2021. Accessed February 22, 2021. https://bit.ly/3uhPIyJ.
3. 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.