Axonics has announced that the US Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation (SNM) system—a technology intended to provide patients suffering from overactive bladder and/or faecal incontinence with long-lived, easy to use, safe and clinically effective therapy.
The newly approved Axonics 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 just once every 6–10 months for only one hour, as per a company press release. This compares to the third-generation’s recharge interval of once per month for one hour.
The Axonics R20 neurostimulator utilises the same small, 5cc form factor as the Axonics R15, and is paired with the same tined lead and intuitive patient remote control. Axonics plans to commercially launch the product in the USA in March.
“Delivering a superior patient experience has been at the forefront of our sacral neuromodulation development efforts,” said John Woock, executive vice president, chief marketing and strategy 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 Axonics R20, which requires recharging just twice per year, represents another significant breakthrough for rechargeable neuromodulation devices and underscores our commitment to continuous innovation.
“We are confident that Axonics’ keen focus on the incontinence patient population and increasing public awareness of sacral neuromodulation has the potential to drive significant market expansion in the years ahead.”