US-based medical technology company Axonics has received the US Food and Drug Administration (FDA) approval for its fourth-generation rechargeable sacral neuromodulation system.
The new-generation neurostimulator, dubbed Axonics R20, is indicated for a functional life in the body as an implanted device for at least 20 years.
It requires to be recharged only once every six to 10 months for only one hour, while the third-generation device requires to be recharged once a month for one hour.
The company said that its Axonics R20 uses the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control.
Axonics intends to commercially launch the product in the US in March this year.
Axonics executive vice president and chief marketing and strategy officer John Woock said: “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.”
Axonics is a medical device company focused on developing and commercialising novel products for the treatment of bladder and bowel dysfunction in adults.
Its sacral neuromodulation (SNM) systems provide patients suffering from overactive bladder or faecal incontinence with long-term, easy-to-use, safe, clinically effective therapy.
Last year, Axonics filed an application with the FDA, seeking premarket approval for its fourth-generation rechargeable sacral neuromodulation implantable neurostimulator.
The company’s third-generation implantable neurostimulator (INS) has been approved in the US, in 2021, and the second-generation rechargeable INS in 2020.
