Medtronic has landed FDA approval for its InterStim Micro neurostimulator and the matching InterStim SureScan MRI leads that are used to treat overactive bladder, fecal incontinence, and non-obstructive urinary retention. The InterStim Micro is a miniaturized version of Medtronic’s InterStim II neuromodulator, being 80% smaller, but it is rechargeable. Thanks to a technology called Overdrive, the battery inside the implant can be recharged repeatedly to full capacity during its 15 year expected lifetime. Both the neuromodulator and the leads have recently been approved for sale in the EU.
Thanks to the SureScan MRI leads that the InterStim Micro relies on, and that are also compatible with the InterStim II neurostimulator, patients will be able to safely receive full body MRI scans, in both 1.5 and 3.0 Tesla machines, as long as certain preparatory steps are taken. Notably, unlike with many other MRI-conditional devices, the InterStim Micro and SureScan MRI leads do not require impedance checks before performing an MRI scan.
Using the InterStim Micro, patients are responsible for keeping the implant charged up, and they can make decisions on where and how to recharge. Since it takes just under an hour to do a complete charge, patients can choose to do quick once a week recharging sessions or longer ones spaced out further apart when they have a full hour to spare for the process.
“I’m excited about the new InterStim technology because it will allow so many more patients to be able to pursue SNM therapy and get back to living life their way,” said Dr. Steve Siegel, urologist at the Centers for Female Urology and Continence Care at Minnesota Urology, in Medtronic’s press release. “The new technology by Medtronic allows me and my patients a choice between a rechargeable or a recharge-free system to best suit their lifestyle, and assures them they can have an MRI. Medtronic has left no box unchecked.”
Product page: InterStim Micro
Flashbacks: InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control; Medtronic’s Tiny New InterStim Micro Neurostimulator Submitted to FDA
Via: Medtronic