FDA approves 4th-generation neurostimulator for fecal incontinence, overactive bladder
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The FDA has approved Axonics Inc’s fourth-generation R20 rechargeable sacral neuromodulation system for bladder and bowel dysfunction.
According to a company release, the R20 neurostimulator has been labeled for a functional life span of at least 20 years, decreasing the frequency with which patients need to recharge their implanted device to once every 6 to 10 months for 1 hour compared with the third generation’s once a month for 1 hour. Like the Axonics R15, the newer R20 uses the same 5cc form factor and has a similar patient remote control.
“Delivering a superior patient experience has been at the forefront of our sacral neuromodulation development efforts,” John Woock, PhD, executive vice president and chief marketing and strategy officer at Axonics, said in the release. “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.”
He continued, “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.”
The company plans to commercially launch the R20 model in the U.S. in March.
Perspective
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Sarah A. Vogler, MD, MBA
A sacral nerve stimulator improves patients’ control of their bowel and bladder continence. Having a treatment such as sacral neuromodulation has been a relief to a lot of these patients, and it has given them the freedom to return to their normal lives. It has been exciting to see this treatment help numerous patients.
There has been a lot of improvement in the sacral neuromodulation technology over the past 10-plus years and the technology continues to improve. The devices are now MRI-safe, smaller in size, rechargeable and have settings that are easier to change, which has led to improved patient response.
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