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FDA Approves Axonics’ Neuromodulation Device For Incontinence

Executive Summary

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

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.

Global Approvals Snapshot September 2019

September’s approvals include the US FDA’s approval of Axonics sacral neuromodulator for fecal incontinence and AMO’s Star S4 IR excimer laser for photorefractive keratectomy.

Results Recap: PRODIGY Supports Medtronic’s Opioid-Related Risk Predictor; Axionics' SNM System For Incontinence Succeeds

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering Feb. 11 through Feb. 21, includes published results from trials of Medtronic's respiratory compromise monitoring system, Agile's contraceptive patch, Affluent's EVAR device for AAA, Abbott's flash glucose monitor, and Axionic's anti-incontinence device.

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