Hot on the heels of the U.S. launch of its recharge-free neurostimulation implant to treat incontinence, Axonics is bringing yet another of its sacral neuromodulation (SNM) devices to our neighbors to the north.
Health Canada has approved the latest version of the R20 neurostimulator—so named because of its 20-year lifespan—Axonics announced Tuesday, adding that sales of the device have already begun in Canada. Like the other SNM implants in Axonics’ portfolio, the R20 is placed near the sacral nerve, where it sends out a continuous current of electrical stimulation to block the abnormal brain signals linked to both urinary and bowel incontinence.
The newly launched version of the R20—the fourth-generation model of the technology—improves upon its predecessors by requiring a recharge for just an hour every six to 10 months throughout its two-decade lifespan. The third-generation model, meanwhile, had to be recharged for an hour every month.
Axonics’ recharging system comprises a wireless charger that is placed over the implant using a stretchy belt or an adhesive carrier, refilling its energy bank through the skin.
Axonics said in this week’s announcement that it’s aiming to expand the R20’s rollout southward within the next few months. It submitted the fourth-gen model for FDA review at the end of the second quarter, CEO Raymond Cohen said during the company’s third-quarter earnings call at the end of October, though the expected U.S. clearance was subsequently hit with a slight delay.
“In August, we participated in what we call a 90-day substantive review meeting with the FDA. The review clock stopped for a few weeks while we prepared our responses to standard questions from the FDA that they had on our submission,” Cohen explained.
With those questions now resolved, the chief executive said Axonics is now expecting the U.S. nod to arrive in January, after which it will begin making the device available to American patients in the first quarter of the year. That launch will be “more limited” than usual, Cohen added later in the call, since Axonics now has multiple SNM options on the market.
Chief among those is the F15 implant, which, as the name suggests, can stay in place for 15 years without requiring a single recharge. The FDA approved the device in March of this year, less than two weeks after Medtronic scored the FDA’s approval for its own recharge-free InterStim X device.
Though Medtronic’s version of the SNM system also boasts a 15-year lifespan, Axonics’ can potentially stretch up to 20 years if energy-saving battery settings are used. Axonics’ implant also offers a slightly smaller footprint than Medtronic’s, with the F15 measuring in at 10 cubic centimeters, compared to the InterStim’s 12.5 cubic centimeters.
Both companies moved swiftly in beginning the commercial launches of their devices: Medtronic’s was available as soon as it announced the regulatory approval in February, and Axonics began rolling out the F15 about a month after its own announcement.