Medtronic receives FDA approval for two new products: InterStim Micro Neurostimulator, InterStim SureScan MRI leads

August 03, 2020 – Medtronic plc (Dublin, Ireland) received approval from the U.S. Food and Drug Administration (FDA) for its InterStim Micro neurostimulator and InterStim SureScan MRI leads. InterStim Micro — the market’s smallest rechargeable device to deliver sacral neuromodulation (SNM) therapy — is used for treating overactive bladder (OAB), fecal incontinence (FI) and non-obstructive urinary retention. The InterStim SureScan MRI leads are used with InterStim Micro and with the recharge-free InterStim II, and allow full-body 1.5 and 3 Tesla MRI-conditional scans.

The two new products make Medtronic the only company to offer a choice in SNM systems to match their preferences, lifestyle and treatment goals. The company says that the product is available for order immediately and will be delivered for patient procedures within days.

Other features of the new InterStim Micro include:

  • 50% smaller than the market’s other rechargeable SNM device
  • Allows patients to choose how and when they want to charge their device — from a quick charge once a week, or as infrequent as once per month, depending on the patient’s preference or device settings.
  • Can recharge from zero to 100% in less than an hour
  • Reduces the need for battery replacement surgeries due to its 15-year lifespan.

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