New recharge-free sacral neuromodulation system for bladder/bowel dysfunction launches in US

Axonics F15, a recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS) for the treatment of patients with bladder and bowel dysfunction, has been commercially launched in the United States.¹

Axonics Inc., the developer of Axonics F15, reported in March 2022 that the FDA had approved the device for use in this setting.2

In a news release announcing the commercial launch, Axonics listed the following device characteristics:

• Type of INS: primary cell battery
• Longevity: At standard stimulation parameters the device is expected to function for 15+ years; at lower energy settings, this extends to 20+ years
• Volume: 10 cm3
• Stimulation: constant current automatically adjusts stimulation output
• MRI compatibility: full body with 1.5T and 3.0T whole-body scanners
• Remote control for patient: recharge-free, intuitive fob

Taylor Moore, MD

“The Axonics recharge-free system is a welcome advancement for patients suffering from bladder and bowel dysfunction,” Taylor Moore, MD, board-certified urologist at Arkansas Urology, stated in the news release.

“My initial implants of the new device have gone well, with low amplitudes achieved at the time of implant suggesting longevity in the body of around 20 years. Clinical outcomes with the Axonics rechargeable SNM system have exceeded our expectations and we anticipate similar results with the Axonics F15. We are pleased to now offer patients a non-rechargeable option that provides significant longevity in the body, constant current stimulation, and a remote control that is recharge-free and easy for patients to use,” added Moore.

Also commenting on the commercial launch in the new release, Raymond W. Cohen, CEO of Axonics, stated, “Physician response to the Axonics F15 has been overwhelmingly positive. Our sales team is now armed with a complete portfolio of SNM products that, along with our national DTC campaign, will contribute to Axonics achieving its mission of treating more adults suffering from incontinence. We remain confident that our commitment to innovation, quality, and providing physicians and patients strong support will continue to drive SNM market expansion and advance Axonics on its path to market leadership.”

References

1. Axonics® Announces Comprehensive Launch of the Axonics F15™ Recharge-Free Sacral Neuromodulation System. Published online April 19, 2022. Accessed April 20, 2022. https://bwnews.pr/3OmP8JY

2. Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System. Published online March 7, 2022. Accessed March 10, 2022. https://bwnews.pr/3sXb5qv