FDA approves new recharge-free sacral neuromodulation system for bladder/bowel dysfunction

The FDA has approved Axonics F15, a recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS) for the treatment of patients with bladder and bowel dysfunction, according to according to Axonics Inc., the developer of the device.¹

Axonics announced the approval in a news release, in which the company 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

“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 Raymond W. Cohen, chief executive officer of Axonics, stated in the news release.

“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 compatibility, a miniaturized implant, fuss-free therapy and a patient remote control that is easy for patients to use. The new Axonics F15 recharge-free SNM system is similarly groundbreaking – a small and thin INS 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,” added Cohen.

Summarizing the need for the novel device, Cohen added, “Tens of millions of Americans suffer from one form or another of incontinence and struggle to find long-term symptom relief. SNM was historically utilized 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.”

Reference

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