Axonics clears FDA to bring latest version of 20-year neurostim implant to US

A month after landing Canadian approval for its updated neuromodulation implant to treat incontinence, Axonics is bringing the fourth-generation R20 device across the border.

The FDA has approved the implant for use in treating bladder and bowel dysfunction, Axonics announced Tuesday. The stateside approval comes about half a year after Axonics put forth the new R20 device to the FDA. In the company’s third-quarter earnings call last year, CEO Raymond Cohen said that the application had been submitted at the end of the second quarter and subsequently sparked a 90-day substantive review period that paused the “review clock” while Axonics answered some questions from the agency about the submission.

At the time, Cohen predicted—correctly—that approval would ultimately arrive in January. The U.S. rollout of the device is now slated to begin in March, according to this week’s announcement, though the CEO noted in the October call that the launch will be “more limited” than those of some of its predecessors since Axonics’ share of the U.S. neurostimulation market is already fairly crowded.

The R20 system is designed to be implanted for at least 20 years. It needs to be recharged for only one hour every six to 10 months—essentially, just twice a year—compared to previous generations of the device that required monthly recharges. The implant is recharged through the skin, using a wireless power bank that’s placed over the device using a stretchy belt or adhesive carrier.

Like Axonics’ other neurostimulators, the R20 device provides sacral neuromodulation therapy. It’s implanted under the skin of the lower back, with electrodes placed on the sacral nerve. The device emits electrical currents that aim to interrupt the abnormal nerve signals between the brain and digestive system that cause incontinence.

Each implant comes with a keychain-sized wireless controller that not only allows users to adjust the intensity of their neurostimulation with the press of a button but also indicates when the implant needs to be recharged.

In a 2020 study (PDF) of Axonics’ rechargeable neuromodulation therapy, 30 of 51 people with overactive bladder responded positively to the treatment within one month of an implant. By the two-year mark, 90% of those responders were still being successfully treated by the system, and 93% reported satisfaction with the therapy.

The upcoming launch of the new-and-improved R20 implant will follow about a year behind Axonics’ last U.S. launch. Last spring, the Southern California company began rolling out its F15 neurostimulator, which had been approved by the FDA mere weeks before.

Though that implant offers a shorter standard lifespan than the R20 device—15 years, as the name implies—it can reach that point without requiring any recharging. Additionally, according to Axonics, the F15 may actually match its newly approved cousin’s two-decade span if energy-saving battery settings are used.