Medtronic kicks off pivotal study of tibial neuromodulation implant for overactive bladder

After receiving an FDA approval last month in bladder and bowel incontinence for its neuromodulation device implanted in the lower back, Medtronic isn’t resting on its laurels. 

It has begun a clinical trial of a similar system placed near the ankle, which the company described as a more convenient option that may make the therapy available to more people.

The medtech giant announced that its first patients have received implants in the pivotal study, with neurostimulators that tap into the posterior tibial nerve running up the back of the leg, to transmit electrical pulses that aim to help regulate an overactive bladder.

Medtronic currently offers tibial neuromodulation through a percutaneous approach with its Nuro system, but that requires patients to visit a clinic and sit through repeated sessions with a needle placed through the skin. 

Meanwhile, the rechargeable InterStim Micro and longer-lasting InterStim X—which received an FDA green light in February, and is designed to go at least a decade without requiring recharging or replacement—are some of the latest models in the company’s 25-year-old product line that targets the body’s sacral nerves at the base of the spine.

Medtronic estimates that more than 37 million adults in the U.S. suffer from overactive bladder, but of the 4.5 million who are candidates for an advanced therapy, only 5% receive treatment. 

The company said that a tibial neuromodulation device would be able to provide ongoing treatment without clinic visits, and would be less invasive compared to sacral implants, which are considered the current standard of care. 

The clinical study is slated to recruit up to 130 participants from as many as 30 sites in the U.S. It will collect data on patients’ progress at the six-month mark and extending to two years in preparation for an FDA submission. The trial follows up on a previous feasibility study launched in April 2021, which explored the safety and efficacy of the tibial implant.

A leg-based device could open up a new front in Medtronic’s head-to-head competition with Axonics Modulation Technologies, where both companies have garnered approvals in sacral neurostimulation devices for incontinence. 

Meanwhile, companies such as BlueWind Medical have been developing their own tibial systems. The Utah and Israel-based BlueWind reported last November that it had completed patient enrollment in an international study of its Renova iStim device for overactive bladder, which includes a miniaturized, leadless neurostimulator implant and a portable wireless device worn over the ankle that powers the twice-daily treatment.

BlueWind said it plans to submit six- and 12-month data from the 150-person study to the FDA this year.