USA – Axonics, a medical technology company based in the United States, has received FDA approval for its newly developed recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS).
The Axonics F15 SNM system has a functional life span of more than 15 years at typical stimulation parameters and more than 20 years at lower-energy settings.
According to Axonics, the system measures 10 cubic centimeters, which is 20% smaller than other non-rechargeable SNM devices currently on the market.
The Axonics F15 SNM system’s constant current automatically regulates stimulation output. The system also includes key fob control that is simple to use and does not require recharging, thanks to SmartMRI technology.
Axonics CEO Raymond Cohen said: “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.
“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.”
According to the medical technology company, the SNM system is MRI compatible for full-body MRI with 1.5T and 3.0T whole-body scanners.
In addition, the system includes a proprietary algorithm that recommends optimal stimulation parameters based on intraoperative responses.
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.”
The company aims to change that paradigm and expect the Axonics F15 system to increase adoption of SNM therapy.
It 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.
In the same space, the FDA recently approved a sacral neuromodulation device from Medtronic, the InterStim X.
The InterStim Micro arrives in the United States months after Axonics Modulation Technologies’ main competitor, the r-SNM implant, which received its first FDA approval last September, but it’s designed to be roughly half as small, with a volume of 2.3 cubic centimeters compared to Axonics’ 5.5 cc.
According to Medtronic, this would make it the world’s smallest rechargeable neurostimulator, and it would be 80 percent smaller than the 14-cc InterStim II, which has been the market leader since 2006.
Axonics is still neck-and-neck with Medtronic in the sacral neuromodulation space, and a cutthroat competition between these two medtech giants in this space.
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