Medtronic Receives FDA Approval for Interstim X System

Medtronic plc, a global leader in healthcare technology, announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ― the next generation of the InterStim™ portfolio’s recharge-free device – and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim™ Micro device. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention.

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

The InterStim X device features:

  • Proprietary 5th 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 InterStim Micro device features:

  • Proprietary Overdrive™ battery technology that offers more than 15 years of battery life with regular recharging once a month, and the smallest, most powerful rechargeable SNM device on the market.

Both systems feature:

  • The first and only smart programmer – a programming device that looks like a common smartphone so patients may discreetly and independently adjust their choice of 11 therapy settings at home or on-the-go.
  • SureScan™ technology that enables full body 1.5T and 3T 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.

“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 personalized therapy options and by reaching them through direct-to-consumer marketing,” said Mira Sahney, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. “As we celebrate 25 years of InterStim this year, we’re bullish about our next chapter in patient-focused therapy innovation.”

 

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