FDA Approves Axonics’ Recharge-Free SNM System

Bladder and bowel dysfunction treatment firm Axonics has received U.S. Food and Drug Administration (FDA) approval for its recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS).
 
The recharge-free SNM device uses a primary cell battery with validated functional life of over 15 years at typical stimulation parameters. It’s MRI compatible for 1.5T and 3T scanners. The system’s remote control is intuitive and programming helps recommend stimulation parameters based on intra-op responses.
 
“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,” Raymond W. Cohen, CEO of Axonics told the press. “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.”
 
Cohen continued, “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. 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.”