Medtronic's rechargeable neurostimulator implant nets FDA approval for bladder and bowel control

After receiving an FDA approval earlier this week for its newly miniaturized and rechargeable sacral nerve stimulator, Medtronic reported that its first patient has received the implant through the Cleveland Clinic, to help treat overactive bladder and fecal incontinence.

The InterStim Micro comes to the U.S. market months after its main competitor offered by Axonics Modulation Technologies, the r-SNM implant—which received its first FDA approval last September—but it’s designed to be about half as small, with a volume of 2.3 cubic centimeters compared to Axonics’ 5.5 cc.

That would make it the world’s smallest rechargeable neurostimulator in the field, Medtronic claims, and 80% smaller than the medtech giant’s 14-cc InterStim II, a market leader since 2006. 

The InterStim Micro’s battery is topped off wirelessly by holding a device on the skin over the implant, and with an implanted lifespan of 15 years, it represents a big upgrade compared to previous models that needed to be surgically replaced every three to five years. 

“We created our entire InterStim portfolio in partnership with physicians backed by a 25-year track record of experience in sacral neuromodulation including over 325,000 implanted patients, 5-year clinical data and more than 1,000 peer-reviewed articles,” said Brooke Story, general manager of Medtronic’s Pelvic Health & Gastric Therapies business. The InterStim Micro previously received a CE mark in January.

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The InterStim Micro, charging pad and
a Samsung device used as a device
programmer (Medtronic)

By sending electrical impulses to the body’s sacral nerves traveling through the lower back, the stimulator aims to improve bladder and bowel control by normalizing the communication between those organs and the brain. Medtronic estimates that over 37 million U.S. adults suffer from overactive bladder, while nearly 18 million have bowel incontinence, but that up to 70% of patients stop taking medications after having side effects or poor results. 

Depending on the device’s settings and the user’s course of therapy, the implant can be recharged quickly once per week or through longer sessions about once per month, and in less than an hour.

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In addition, and similar to Axonics’ r-SNM implant, the InterStim Micro and its electrical leads are deemed safe for full-body MRI scans. Medtronic said its device is available for order immediately as part of a comprehensive U.S. commercial launch.