September 19, 2025- Medtronic plc announced that it has received U.S. Food and Drug Administration (FDA) approval for the Altaviva™ device. The minimally invasive implantable tibial neuromodulation (ITNM) therapy is inserted near the ankle and designed to treat urge urinary incontinence.
Bladder control problems affect an estimated 43 million – or one in six – U.S. adults. Of those, nearly 16 million people have urge urinary incontinence, a common symptom of overactive bladder (OAB) characterized by a sudden, intense urge to urinate, often followed by involuntary leaks before reaching the bathroom. However, only a quarter of people with general bladder control issues have discussed their symptoms with a doctor. These conditions can affect quality of life, mental health, and sleep, while also posing a significant economic burden on both society and patients.
Patients who receive an Altaviva device return home with therapy activated, a first among implantable tibial devices for urge urinary incontinence. The device is inserted near the ankle during a minimally invasive procedure that doesn’t require sedation or imaging.