Medtronic receives FDA approval for InterStim X system for bladder and bowel control

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Medtronic has announced receipt of approval from the US Food and Drug Administration (FDA) for its new, recharge-free InterStim system—with the device being made available immediately for the treatment of overactive bladder, chronic faecal incontinence, and non-obstructive urinary retention.

“Countless people suffer from symptoms of bladder and bowel control conditions, and, thanks to significant recent technology advancements, SNM [sacral neuromodulation] therapy is becoming a more popular option for patients,” said Jannah H Thompson (Urologic Consultants, Grand Rapids, USA), president of the Society of Women in Urology. “This is not your grandmother’s therapy. It is exciting to tell patients about the personalised, discreet, smart tech-enabled InterStim choices they now have for long-term relief.”

According to a Medtronic press release, InterStim systems are the standard of care in advanced therapy options, and the most personalised system, to deliver SNM therapy.

The company’s new, recharge-free InterStim X device is described as featuring proprietary, fifth-generation battery chemistry that offers more than 10 years of battery life without the need to recharge—providing patients with more freedom and less maintenance. With low energy settings, the device may last up to 15 years, the release adds.

In addition to the recharge-free feature, the new InterStim X device has several aspects in common with Medtronic’s established, rechargeable InterStim Micro device, including a smart programmer that looks like a common smartphone and allows patients to discreetly and independently select their choice from 11 therapy settings at home, or on-the-go.

Both systems also feature SureScan technology, which enables full body 1.5T and 3T magnetic resonance imaging (MRI) scans under certain conditions and does not require impedance checks. MRI mode is easy for patients to independently activate or deactivate on the smart programmer as well, according to the release.

The SNM system is backed by more than 90 clinical studies, 1,000-plus clinical articles, 350,000 patients treated and 25 years of experience, Medtronic claims.


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