Axonics® announces first commercial u.s. patient implanted with its sacral neuromodulation system

Axonics modulation technologies, inc. announced the first u.s.-based implantation of the axonics r-snm® system subsequent to its clearance by the united states food & drug administration (“fda”) in september. following the completion of customary post-approval regulatory activities, the first implant outside of a clinical study setting was conducted in california on october 29. the axonics r-snm system offers a long-lived miniaturized neurostimulator that is approximately the size of a usb stick and is qualified to operate for at least 15 years. unlike some active implantable devices, the axonics device can safely be left in place during full-body mri scans. recently, axonics received fda approval granting the company the right to market its product in the united states for the clinical indication of fecal incontinence. additional conditions are under fda review, including overactive bladder (urinary urge incontinence and urinary urge frequency) as well as urinary retention.
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