FDA approves Medtronic's long-lasting neurostimulator implant for bladder, bowel incontinence

In 2020, hot on the heels of Axonics Modulation Technologies’ FDA approval for a rechargeable neuromodulation implant to treat urinary and bowel dysfunction, Medtronic scored a regulatory win of its own for the InterStim Micro device. Like its competitor’s offering, the implant was designed to triple the lifespan of previous devices, staying in place for up to 15 years, but it clocked in at about half the size of Axonics’ r-SNM device.

Less than two years later, Medtronic announced the FDA has approved InterStim's newest version, designed to go at least a decade without requiring recharging or replacement. Commercial rollout of the device has already begun.

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Like its predecessors, the InterStim X is implanted at the lower back and wired to the sacral nerve. The devices deliver electrical stimulation directly, with an aim of regulating nerve functions that can cause overactive bladder, chronic fecal incontinence and non-obstructive urinary retention.

Though larger than the rechargeable InterStim Micro—which took up only about 2.8 cubic centimeters, compared to the InterStim X’s 12.5—the new implant doesn’t require any routine maintenance, such as weekly charging sessions.

The device’s battery is designed to last at least 10 years before the implant must be replaced. Medtronic also said it could potentially last up to 15 years—the lifespan of the rechargeable iteration—if energy-saving settings are used.

Both the X and Micro implants are controlled by what Medtronic describes as a “smart” programmer for sacral neuromodulation devices. The patient-controlled programmer looks like a standard smartphone, allowing for portable and discreet adjustments to therapy settings. It can also be used to turn on “MRI mode,” making the devices safe for scans under certain conditions.

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Axonics is still neck-and-neck with Medtronic in the sacral neuromodulation space. The company anticipates receiving the FDA’s approval for its own recharge-free implant later this year.

“We expect to begin shipping our long-lived, recharge-free [sacral neuromodulation] system in early second quarter,” the devicemaker’s CEO, Raymond Cohen, said in a year-end financial report released Thursday, which showed that Axonics’ annual revenue from its implants increased 25% in 2021, to a total of $197 million.

Medtronic’s latest earnings report, meanwhile, showed that its entire neuromodulation segment had earned $409 million for the three-month period ending Jan. 28, down 4% year over year.