Medtronic receives CE mark for InterStim Micro Neurostimulator and InterStim SureScan MRI leads

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Medtronic has announced it has received CE mark for its InterStim Micro neurostimulator and InterStim SureScan MRI leads—clearing the technologies for commercial sale and clinical use in Europe. The availability of the new technologies on 15 January will expand access to sacral neuromodulation (SNM) therapy for thousands of potential European patients by offering full-body MRI scan eligible, lifestyle-friendly choices with either the InterStim Micro or InterStim II neurostimulators.

InterStim Micro is a rechargeable device that delivers sacral neuromodulation therapy to treat overactive bladder (OAB), faecal incontinence (FI) and non-obstructive urinary retention. It is 80% smaller than the existing recharge-free InterStim II neurostimulator and could reduce the need for battery replacement surgeries due to its life of 15 years. It also features proprietary Overdrive battery technology—a battery with virtually no loss in capacity over time—that provides simple and rapid recharging. The SureScan leads, which will be used in both the InterStim Micro system and in future implants of the existing recharge-free InterStim II, are designed to allow for full-body 1.5 and 3 Tesla MRI-conditional scans.

Between 4–8% of the world’s population suffer from incontinence. In addition, at least half of patients with pacemakers or neurostimulators will have a clinical indication for an MRI examination over their lifetime, and up to 23% of SNM explants are currently due to the need for an MRI scan.

Medtronic has treated more than 300,000 patients with recharge-free InterStim systems and, now, the rechargeable InterStim Micro and SureScan leads for the InterStim Micro and InterStim II systems will allow even more patients to access the therapy. According to Medtronic, it is the only company in Europe to offer patients a choice between rechargeable and recharge-free systems that are both full-body MRI-conditional.

“Effective long-term bladder and bowel control is an under-met medical need for many who experience regular accidents and/or frequency issues associated with OAB and FI,” said Philip EV Van Kerrebroeck; professor of Urology, Maastricht University Medical Centre, Maastricht, the Netherlands. “The new capabilities offered by MRI-conditional InterStim II and InterStim Micro will give patients the ability to choose a system that is compatible with their lifestyle, and they can have an MRI without being explanted.”


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