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FDA Expands Indication For Axonics’ Incontinence System; Medtronic Claims Patent Infringement

Executive Summary

The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The agency approved the same device for treating chronic fecal incontinence on 9 September. Axonics expects r-SNM to rival Medtronic's InterStim II non-rechargeable sacral neuromodulation system, but Medtronic claims the r-SNM technology infringes on Medtronic’s intellectual property.

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FDA Approves Axonics’ Neuromodulation Device For Incontinence

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.

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