Axonics receives FDA approval for new recharge-free sacral neuromodulation system

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Axonics has announced that the US Food and Drug Administration (FDA) has approved its newly developed, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator, the Axonics F15 system, for adult patients with bladder and bowel dysfunction.

In a press release, Axonics claims that the device sets a “recharge-free neuromodulation benchmark” with FDA labelling for 15-plus years of functional life at typical stimulation parameters, increasing to 20-plus years at lower energy settings.

“Axonics is keenly focused on developing innovative, best-in-class, patient-centric SNM solutions as well as expanding awareness and access to this life-changing therapy,” said Axonics CEO Raymond W Cohen. “Our rechargeable system introduced innovations to the SNM category in late 2019 that clinicians and patients had been requesting for years—longevity in the body, full-body MRI [magnetic resonance imaging] compatibility, a miniaturised implant, fuss-free therapy and a remote control that is easy for patients to use.

“The new Axonics F15 recharge-free SNM system is similarly groundbreaking—a small and thin implantable neurostimulator with an expected life in the body of well over a decade that does not require any element of the system to be recharged—and sets a new standard for what is possible in this category. We expect to begin shipping the Axonics F15 system in April.”

The newly approved system also features the following attributes:

  • Stimulator type: primary cell battery
  • Stimulator volume: 10 cubic centimeters (20% smaller than the market’s other non-rechargeable SNM device, according to Axonics)
  • Stimulation: constant current automatically adjusts stimulation output
  • MRI compatibility: full body with 1.5T and 3.0T whole-body scanners
  • Patient remote control: intuitive, recharge-free key fob featuring SmartMRI technology
  • Programming: proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses.

“Tens of millions of Americans suffer from one form or another of incontinence and struggle to find long-term symptom relief,” Cohen continued. “SNM was historically utilised as a therapy of last resort, as it was only available with a neurostimulator that had an average battery life of four years, requiring patients to undergo multiple replacement surgeries. We aim to change that paradigm and expect the Axonics F15 system to increase adoption of SNM therapy.

“We will also launch a national television direct-to-consumer advertising campaign in the coming weeks to increase awareness for Axonics therapies, which treat all forms of bladder and bowel incontinence. We remain confident that our commitment to innovation, quality, and providing physicians and patients strong support, will continue to drive market expansion and advance Axonics on its path to market leadership.”


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