The Axonics system is the first rechargeable SNM system approved for sale in the US, Europe, Canada and Australia
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
Axonics Modulation Technologies has secured approval from the US Food & Drug Administration (FDA) for its r-SNM sacral neuromodulation system.
Axonics r-SNM is a novel implantable rechargeable sacral neuromodulation (SNM) device developed to treat urinary and bowel dysfunction.
Axonics r-SNM rechargeable SNM system
The r-SNM system is claimed to be the first rechargeable SNM system that has secured approval for commercialisation in the US, Europe, Canada and Australia.
The FDA approval allows Axonics to market the new system in the US for clinical indication of fecal incontinence.
According to the company, the approval comprises the claim of a 15-year functional life and the capacity of patients to undergo full-body MRI scans without the necessity of having the device explanted.
The firm has an additional pre-market approval (PMA) filing presently under assessment with the FDA for the clinical indications of overactive bladder and urinary retention.
Axonics r-SNM system is said to provide a long-lived miniaturised neurostimulator that is around the size of a USB stick and needs patients to undergo a surgical intervention to replace the device every three to five years.
The system is also provided with patented tined lead, user-friendly accessories and wireless charging system optimised for infrequent charging, as well as small easy-to-use patient remote control and an advanced clinician programmer that enables lead placement and stimulation programming.
The approval of the new system was based on the results of the ARTISAN-SNM 129-patient pivotal clinical study, which achieved all primary and secondary endpoints. The study was carried out at 14 centres in the US and five centers in Western Europe.
Axonics CEO Raymond Cohen said: “If we consider the millions of women who are suffering in silence with bladder and bowel dysfunction, we believe the market opportunity for Axonics goes well beyond the existing approximately $650 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device.
“We believe the number of patients seeking SNM treatment will expand dramatically over the next few years given our fuss-free, long-lived, full body MRI-compatible device.”
In February this year, Axonics secured CE mark approval for 1.5T and 3T full-body magnetic resonance imaging (MRI) conditional labeling for the Axonics r-SNM system.