Axonics has announced that Health Canada has approved the company’s fourth-generation rechargeable sacral neuromodulation system as a treatment for bladder and bowel dysfunction.
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 once every 6–10 months, and for only one hour, the company claims in a press release. This compares to the third-generation’s recharging interval of once a month for one hour.
The Axonics R20 neurostimulator utilises the same small 5cc form factor as the third-generation device, and is paired with the same tined lead and intuitive, easy-to-use patient remote control, the release also notes.
“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of our development efforts,” said Raymond W Cohen, the company’s CEO. “Patients with overactive bladder want efficacy and a long-lived solution to address their chronic condition. The Axonics R20 represents a 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.”
Axonics has commenced sales of the R20 sacral neuromodulation system to customers in Canada.
The device is currently under review by the US Food and Drug Administration (FDA) too, with Axonics anticipating approval and planning to commercially launch the product in the USA in the first quarter of 2023.