Neuromodulation Device for Urinary Incontinence Cleared by FDA
The Food and Drug Administration (FDA) has approved Altaviva (Medtronic, Galway, Ireland), a minimally invasive tibial neuromodulation (ITNM) device designed to treat urge urinary incontinence (UUI), a condition affecting nearly 16 million people in the United States. UUI is a common symptom of overactive bladder and can be a complication associated with neurologic disorders including but not limited to multiple sclerosis, Parkinson disease, stroke, spinal cord injury, and dementia.
Altaviva is implanted just above the fascia near the ankle in a brief outpatient procedure that does not require sedation or imaging. According to a statement released by Medtronic, the device is a few centimeters in length and delivers electrical stimulation to the tibial nerve, which helps re-establish communication between the bladder and brain to regulate bladder control. Therapy is activated immediately after placement, and the system operates automatically without daily patient adjustments. The device is designed with an estimated 15-year battery life, requires recharging only every few weeks, and does not need to be removed before MRI.
FDA clearance was supported by findings from the pivotal TITAN 2 study (NCT05226286), which evaluated the device’s safety and efficacy in 188 people with UUI. According to Medtronic, results showed significant reductions in urgency episodes and incontinence events among participants using Altaviva, with an overall safety profile comparable to other neuromodulation therapies. A company statement reports 5 adverse events related to the device or procedure including 1 serious wound infection.
Source: Medtronic. Medtronic secures FDA approval for the Altaviva™ device, a simple experience for treating urge urinary incontinence. news.medtronic.com. Published 19 September, 2025. Accessed 19 September, 2025. https://news.medtronic.com/2025-09-19-Medtronic-secures-FDA-approval-for-the-Altaviva-TM-device,-a-simple-experience-for-treating-urge-urinary-incontinence