FDA approves Medtronic's recharge-free InterStim system

Medtronic announced that it received FDA approval for InterStim X, its next-generation sacral neuromodulation (SNM) therapy system for bladder and bowel control. The SNM device, which provides 10 to 15 years of battery life without the need to recharge, is available immediately for the treatment of bladder (OAB), chronic faecal incontinence and non-obstructive urinary retention.

Mira Sahney, president of Medtronic's pelvic health business, said "we're on a mission to expand access to proven nerve stimulation therapies through technology advancements like InterStim X, InterStim Micro, SureScan MRI technology and the smart programmer, by offering patients personalised therapy options and by reaching them through direct-to-consumer marketing." She added "as we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation."

In 2020, Medtronic received FDA approval for its rechargeable InterStim Micro SNM therapy system and InterStim SureScan magnetic resonance imaging (MRI) leads for the treatment of OAB, chronic faecal incontinence and non-obstructive urinary retention. Last year, Medtronic was granted FDA approval for expanded MRI labelling of its InterStim II and InterStim Micro SNM systems that use SureScan MRI leads.

As with InterStim Micro, InterStim X features a programming device that enables patients to discreetly and independently adjust their choice of 11 therapy settings. Both systems also come with SureScan technology that allows full body 1.5T and 3T MRI scans under certain conditions, and does not require impedance checks.

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