Axonics modulation technologies, inc. announces u.s. food & drug administration approval for its sacral neuromodulation system for urinary clinical indications

Axonics modulation technologies, inc. announced the approval of the axonics r-snm® system by the united states food & drug administration for the clinical indications of overactive bladder and urinary retention. the fda premarket approval grants axonics the right to market its product in the united states for the clinical indications of oab (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for snm devices. the fda approval follows the company’s september approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. the fda approval was supported by the results of a detailed review of technical data and the positive results of the axonics artisan-snm 129-patient pivotal clinical study that met all primary and secondary endpoints and demonstrated 90% efficacy for all implanted urinary incontinence patients at six months, as well as published clinical literature. the axonics r-snm system is the first rechargeable snm system approved for sale in the u.s., europe, canada and australia. it is also the only snm device approved for patients to undergo full-body mri scan without the necessity of having the device explanted. the fda approval includes the claim of a 15-year functional life, which is in contrast to the incumbent company’s legacy device which requires replacement on average every four years. in addition to many other differentiating attributes, the system includes a patented tined lead, user-friendly accessories, such as a wireless charging system optimized for infrequent charging, a small easy-to-use key-fob patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming. the long-lived miniaturized neurostimulator is approximately the size of a usb stick.
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