Medical technologies developer Axonics Modulation Technologies has received the US Food and Drug Administration (FDA) approval for its rechargeable sacral neuromodulation (r-SNM) System to treat faecal incontinence.
The approval also includes a claim of a 15-year functional life, as well as access to full-body magnetic resonance imaging (MRI) scans without the need for removal of the implantable, rechargeable device from the body.
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Furthermore, the device is being reviewed by the regulator for pre-market approval in overactive bladder and urinary retention indications.
Sacral neuromodulation is a treatment indicated for bladder and bowel dysfunction, which occur due to inappropriate communication between the bladder and the brain.
The therapy has been in use to mitigate symptoms and restore pelvic floor function.
Axonics have said that r-SNM System is the first of its kind to secure approval for trade in the US, Europe, Australia and Canada and also holds full-body MRI conditional labelling.
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By GlobalDataThe device comes with a small neurostimulator, tined lead, accessories and a wireless charging system to facilitate less frequent charging.
It also has a small patient remote control and an intuitive clinician programmer for lead placement and stimulation programming.
FDA approval stems from the safety and effectiveness data from the ARTISAN-SNM pivotal study conducted in 129 patients at 14 centres in the US and five sites in Western Europe.
ARTISAN-SNM met all primary and secondary goals without any severe device-related adverse events.
Axonics Modulation Technologies 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 $650m 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.”
The company plans to make the r-SNM System available for physicians and hospitals in the US during the fourth quarter of the year.
Axonics secured the European CE-Mark approval for MRI conditional labelling for the r-SNM system in February.
