Medtronic wins FDA approval for new tibial neuromodulation device

Medtronic receives FDA approval for tibial neuromodulation device: ©Tada Images - stock.adobe.com

Medtronic plc announced that the U.S. Food and Drug Administration has approved its Altaviva implantable tibial neuromodulation (ITNM) device, a minimally invasive therapy for patients with urge urinary incontinence.

The device, implanted near the ankle, delivers electrical impulses to the tibial nerve to help restore communication between the bladder and brain. Unlike previous options, patients go home with the therapy already activated, avoiding the need for daily adjustments.

Bladder control issues affect an estimated 43 million Americans, with nearly 16 million experiencing urge urinary incontinence, a symptom of overactive bladder characterized by sudden urges followed by involuntary leakage. Despite its prevalence, only about one in four people with bladder control problems have discussed symptoms with a doctor, according to the company.

“The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” said Kevin Benson, a urogynecologist at Sanford Health and investigator in the Altaviva pivotal study. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives.”

The device, about half the length of a stick of chewing gum, sits below the skin and above the fascia. It is designed for a 15-year battery life and requires only occasional 30-minute recharging. It is also MRI-compatible.

“Too many people silently struggle with urgency and loss of bladder control, often believing that relying on diapers or pads is their only option,” said Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio. “The Altaviva device represents a transformative milestone and ushers in a new bladder control therapy with advanced features.”

With the Altaviva approval, Medtronic becomes the only company offering a full suite of neuromodulation therapies for bladder control.

Advancements in neuromodulation therapies for bladder control

The approval of new implantable devices reflects a broader trend in the evolution of neuromodulation therapies for bladder control. Traditionally, patients managing urge urinary incontinence or overactive bladder had limited treatment choices—primarily behavioral therapy, medications, or more invasive surgical options. In recent years, minimally invasive neuromodulation technologies have emerged as a middle ground, providing effective symptom control while avoiding the drawbacks of drug side effects or major procedures.

One of the most important advancements is the refinement of implantable tibial neuromodulation (ITNM), which targets the tibial nerve near the ankle. By using small electrical impulses to retrain bladder-brain communication pathways, ITNM provides a more targeted approach than systemic drugs. Improvements in device design—such as longer-lasting batteries, simplified recharging, and MRI compatibility—are making these therapies more accessible and less disruptive for patients’ daily lives.

Another notable development is the emphasis on patient-centered features. Devices are increasingly being designed for ease of use, requiring minimal maintenance once implanted. This reduces the burden of therapy adherence and expands options for patients who might otherwise avoid treatment.

Researchers are also exploring how digital health integration can complement neuromodulation therapies. Remote monitoring and data collection may one day allow clinicians to track treatment effectiveness and adjust therapy settings without requiring frequent in-person visits.

Together, these innovations are reshaping how clinicians and patients view bladder control therapies. Instead of managing symptoms as an inevitable part of aging, newer technologies offer long-term, low-maintenance solutions that prioritize quality of life. For millions living with the stigma and daily challenges of bladder dysfunction, these advancements represent not just medical progress, but the possibility of reclaiming independence and confidence.