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Medtronic Announces FDA Submission For InterStim Micro Neurostimulator

Medtronic plc. (MDT) said Monday that it has filed a pre-market approval or PMA supplement with the United States Food and Drug Administration or FDA for approval of its InterStim Micro neurostimulator and also its InterStim SureScan MRI leads.

InterStim Micro is a rechargeable, implantable sacral neuromodulation or SNM device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence.

The SureScan leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval.

The rechargeable InterStim Micro device works by sending electrical impulses to the sacral nerves, normalizing the connections between the brain, bladder and bowel. It is 80% smaller than the current recharge-free InterStim II neurostimulator and could reduce the need for battery replacement surgeries due to its life of 15 years.

In addition, the SureScan full-body conditional MRI leads will enable patients to undergo imaging procedures that were not previously indicated under the current FDA approval for the InterStim II system.

The submission, pending regulatory approval from the FDA, would position the Company to achieve approval for the InterStim Micro system and SureScan MRI leads in the spring of 2020, following a standard 180-day review process.

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