Medtronic has announced that the first patient has been treated with its newly FDA-approved Altaviva neuromodulation device for urge urinary incontinence (UUI). The first commercial procedure took place less than a week after the implantable tibial neuromodulation (ITNM) system received FDA clearance. Dr. Keith Xavier performed the procedure at Surgical Centers of North Texas.
The Altaviva device, a minimally invasive ITNM system, is implanted near the ankle to treat UUI. Patients leave the facility with the therapy already activated. Medtronic — one of the world’s largest medical technology companies — says this is a first for implantable tibial devices addressing UUI. The implantation is minimally invasive and requires no sedation or imaging.
“Many of my patients who struggle with urgency and involuntary leaks are candidates for the Altaviva device, and it was incredibly rewarding to be able to tell one of them, ‘It’s here—and not only that, but we coordinated with your health insurance, and you can get it this week,’” said Dr. Xavier. “It’s exciting to offer this simple option for treating urge urinary incontinence, and I look forward to seeing how this therapy can improve lives.”
Altaviva measures about half the length of a stick of chewing gum and is positioned just below the skin and above the fascia to deliver electrical impulses to the tibial nerve. This stimulation helps restore communication between the bladder and the brain, improving bladder control. The device has an expected battery life of 15 years under normal therapy settings and delivers therapy automatically, requiring no daily intervention or manual adjustments. Recharging takes up to 30 minutes using the default speed, eliminating the need for daily at-home charging.
According to Medtronic, nearly 16 million adults in the U.S. experience urge urinary incontinence, a condition characterized by sudden urges to urinate, often followed by involuntary leakage, which can significantly impact daily life.
“It’s a privilege to see the Altaviva device available in the U.S. so soon after FDA approval. This is an important milestone for patients with urge urinary incontinence, many of whom have been told for too long that losing bladder control is just part of aging,” said Emily Elswick, president of the Pelvic Health business within Medtronic’s Neuroscience Portfolio. “The Altaviva device is designed to empower patients with a simple experience and is the result of an incredible team committed to offering renewed hope for a better quality of life.”