Medtronic plc, a leading company in healthcare technology, has announced that the U.S. Food and Drug Administration has approved its Altaviva device. This minimally invasive, implantable device uses tibial neuromodulation to treat urge urinary incontinence by sending electrical impulses to the tibial nerve near the ankle. The device is intended for individuals who experience a sudden, strong urge to urinate, often resulting in accidental leakage before they can reach a bathroom. This condition affects almost 16 million adults in the United States. Even though it is common, many people do not seek medical treatment, which can affect their quality of life, mental well-being, sleep, and create financial difficulties.
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Dr. Kevin Benson, a urogynecologist at Sanford Health and a key investigator in the pivotal TITAN 2 study, called the Altaviva device a groundbreaking development. He noted that many patients avoid seeking treatment because they are worried about the invasiveness of procedures and potential side effects. Dr. Benson is hopeful that the Altaviva device offers a less invasive and simpler alternative that can significantly improve patients’ lives by delivering an effective and easy-to-use solution.
The Altaviva device is implanted just beneath the skin and above the fascia near the ankle during a quick, minimally invasive procedure that does not require sedation or imaging. It is about half the size of a stick of gum and starts working immediately, making it the first implantable tibial neuromodulation therapy that can be used right after a patient is discharged from the hospital. The device sends electrical signals to the tibial nerve, helping to restore communication between the brain and bladder, which can lead to better control. The battery life of the device is expected to last up to 15 years under normal use, and recharging is needed only occasionally, taking about 30 minutes at the standard charging rate. The Altaviva device is also compatible with MRI scans, which provides patients with reassurance for future imaging needs.
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Emily Elswick, President of Medtronic’s Pelvic Health business within the Neuroscience Portfolio, pointed out that society has long viewed bladder control loss as a normal part of life, but this perspective needs to change. She explained that the Altaviva device is designed to offer a simple, effective treatment that helps patients regain control and enhance their daily lives. Elswick expressed pride in bringing this technology to market, offering renewed hope for individuals affected by urge urinary incontinence.
Brett Wall, Executive Vice President and President of Medtronic’s Neuroscience Portfolio, acknowledged the challenges many people face in silence due to bladder control issues and the misconception that pads or diapers are the only options. He described the Altaviva device as a major advancement in bladder therapy, with advanced features. Wall reiterated Medtronic’s commitment to innovation and its leadership in neuromodulation therapies that significantly improve patient lives. Medtronic has a long history of over 30 years of developing neuromodulation devices to address bladder control problems. With the Altaviva device now approved, the company provides the most comprehensive range of neuromodulation treatments available for urge urinary incontinence. Medtronic will host an investor call on October 9, 2025, at 10 a.m. CST, where Emily Elswick will discuss the Altaviva device and its role in changing the way this condition is treated.
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