On Medtronic's tail, Axonics scores FDA nod for 15-year neurostim implant for incontinence

The race to treat a number of health conditions using neurostimulation technology is a marathon, not a sprint—but Medtronic and Axonics Modulation Technologies are still aiming for a photo finish.

For years now, as each of the companies has achieved scientific and regulatory milestones, the other has typically been able to follow suit within just a few months or even weeks, often one-upping its competitor in the process.

That’s the case in the latest round of FDA approvals for Medtronic and Axonics, both of whom snagged the agency’s go-ahead for the newest iterations of their respective sacral neuromodulation (SNM) implants to treat urinary and bowel incontinence.

The approvals arrived less than two weeks apart: The first went to Medtronic for its InterStim X device, and now, Axonics has received an agency OK for its own F15 neurostimulation system.

Like the InterStim X, Axonics’ F15 implant is designed to deliver electrical stimulation directly to the sacral nerve, blocking the neurological signals linked to bladder and bowel dysfunction.

However, Axonics’ version of the SNM technology outstrips its competitor by offering a recharge-free lifespan of at least 15 years when programmed at standard parameters, and up to 20 years when the battery’s energy-saving settings are used. The maximum lifespan of Medtronic’s recharge-free device, meanwhile, is 15 years.

Axonics also slimmed down the technology: Its F15 implant clocks in at just 10 cubic centimeters, compared to the InterStim X’s 12.5 cubic centimeters.

Both devices are compatible with 1.5T and 3.0T MRI scanners, and both Medtronic and Axonics allow patients to put their implants into “MRI mode” using an external controller—a smartphone-inspired programmer for Medtronic’s devices and a key fob for Axonics’.

Staying hot on the heels of its competitor, which has already begun commercial rollout of the InterStim X system, Axonics is planning to begin shipping the F15 system next month, CEO Raymond Cohen said in a statement.

He added that the company will also unveil a direct-to-consumer ad campaign to “increase awareness” of Axonics’ offerings to treat all forms of urinary and fecal incontinence.

“Tens of millions of Americans suffer from one form or another of incontinence and struggle to find long-term symptom relief. SNM was historically utilized as a therapy of last resort as it was only available with a neurostimulator that had an average battery life of four years, requiring patients to undergo multiple replacement surgeries,” Cohen said. “We aim to change that paradigm and expect the Axonics F15 system to increase adoption of SNM therapy.”