The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence.
The approval indicates the Axonics R20 for a functional life in the body of at least 20 years. It also reduces the frequency with which a patient must recharge their implanted device, cutting it to once every 6-10 months. Charging takes only one hour.
According to a news release, this improves upon the third generation’s recharge interval of once a month for one hour.
The Axonics R20 neurostimulator uses the same small 5cc form factor as the previous-generation R15. It pairs with the same tined lead and intuitive patient remote control.
Axonics said it expects to commercially launch the R20 neurostimulation in the U.S. in March. The same system received Canadian approval last month.
John Woock, EVP and chief marketing and strategy officer at Axonics, said this marks another step in driving significant market expansion for the company.
“Delivering a superior patient experience has been at the forefront of our sacral neuromodulation development efforts,” said Woock. “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.”