Sam Brusco, Associate Editor03.18.24
Axonics has gained CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.
The R20 neurostimulator has functional life in the body of at least 20 years and lowers how much a patient must recharge the implanted device to once every six to 10 months for an hour. It uses the same 5cc form factor as the previous generation R15 and is paired with the same tine lead and intuitive patient remote control.
R20 also includes enhanced programming capabilities and expanded MRI labeling. Axonics plans to begin R20 sales to European customers in mid-April. It received U.S. Food and Drug Administration (FDA) approval in January 2023.
“Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said Raymond W. Cohen, Axonics’ CEO. “Patients with overactive bladder tell us that first and foremost, they value efficacy and a long-lived solution to address their chronic condition. The R20 represents another significant breakthrough for rechargeable neuromodulation devices and underscores Axonics’ commitment to continuous innovation. We are confident that our keen focus on the incontinence patient population has the potential to drive significant market expansion in both the U.S. and international markets in the years ahead.”
The company is currently embroiled in patent litigation with Medtronic, who recently asked the FTC to halt sales of its neuromodulation devices in the U.S. It also entered an agreement to be acquired by Boston Scientific earlier this year.
The R20 neurostimulator has functional life in the body of at least 20 years and lowers how much a patient must recharge the implanted device to once every six to 10 months for an hour. It uses the same 5cc form factor as the previous generation R15 and is paired with the same tine lead and intuitive patient remote control.
R20 also includes enhanced programming capabilities and expanded MRI labeling. Axonics plans to begin R20 sales to European customers in mid-April. It received U.S. Food and Drug Administration (FDA) approval in January 2023.
“Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said Raymond W. Cohen, Axonics’ CEO. “Patients with overactive bladder tell us that first and foremost, they value efficacy and a long-lived solution to address their chronic condition. The R20 represents another significant breakthrough for rechargeable neuromodulation devices and underscores Axonics’ commitment to continuous innovation. We are confident that our keen focus on the incontinence patient population has the potential to drive significant market expansion in both the U.S. and international markets in the years ahead.”
The company is currently embroiled in patent litigation with Medtronic, who recently asked the FTC to halt sales of its neuromodulation devices in the U.S. It also entered an agreement to be acquired by Boston Scientific earlier this year.