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FDA Approves Axonics’ Neuromodulation Device For Incontinence

 
• By Reed Miller

The US FDA has approved r-SNM sacral neuromodulation system for treating chronic fecal incontinence and Axonics expects the agency to approve it for overactive bladder and urinary retention in the next few weeks. The company expects r-SNM to compete with Medtronic's Interstim non-rechargeable sacral neuromodulation system.

Approved stamp
• Source: shutterstock.com

The US Food & Drug Administration approved Axonics Modulation Technologies Inc.’s rechargeable sacral neuromodulation (r-SNM) system for treating chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments, Axonics announced on 9 September.

The FDA is also reviewing another PMA for r-SNM for the indications of overactive bladder – both urinary urgency incontinence and urinary urgency frequency – and urinary retention. The company...

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