Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention.
The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but it is a rechargeable device with an expected longevity of about 15 years. This is made possible partially thanks to so-called Overdrive technology that lets the battery maintain almost its full capacity to recharge throughout its working life.
The SureScan MRI leads that come with the InterStim Micro, and which will also be available with the InterStim II, will let patients with the implants to continue to receive MRI (both 1.5 and 3 Tesla) scans as necessary, given certain precautions are taken.
“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 E.V. Van Kerrebroeck, M.D., Ph.D., MMSc; professor of Urology, Maastricht University Medical Centre, the Netherlands, in a Medtronic press release. “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. I’m excited because it allows me to offer the trusted experience and support of Medtronic to help give my patients their lives back.”
“We’re excited our most recent technology advances in sacral neuromodulation will allow physicians to treat more patients who need relief from their symptoms,” said Brooke Story, VP and general manager of the Pelvic Health and Gastric Therapies business, part of Medtronic’s Restorative Therapies Group. “We pioneered this therapy 25 years ago in partnership with physicians, and we have the only five-year data for all indications to demonstrate its safety and efficacy. We know from deep experience that it’s important the therapy accommodates the lifestyle of the patient to produce the best outcome, and our latest innovations will now offer them a lifestyle-friendly choice in Medtronic SNM systems.”
Flashbacks: Medtronic’s Tiny New InterStim Micro Neurostimulator Submitted to FDA; InterStim Incontinence and Bladder Control Implant Now Controlled via App; InterStim II System for Sacral Nerve Stimulation; Medtronic’s InterStim Therapy Continues to Show Encouraging Results at 3-Year Follow Up; InterStim Sacral Nerve Stimulation for Bowel Control Is Now Option in US; Medtronic’s Verify Sacral Neuromodulation Trial System FDA Approved for Basic Evaluations of Bladder, Bowel Control