Medtronic (NYSE: MDT) today reported the first patient treated with its Altaviva neuromodulation device for urge urinary incontinence.
The first commercial procedure comes less than a week after the implantable tibial neuromodulation (ITNM) system won FDA approval. Dr. Keith Xavier performed the procedure at Surgical Centers of North Texas.
Altaviva, a minimally invasive implantable tibial neuromodulation (ITNM) device, is inserted near the ankle and designed to treat urge urinary incontinence (UUI).
Patients who receive an Altaviva device return home with therapy activated. Medtronic — one of the largest medtech companies in the world — says this marks a first among implantable tibial devices for treating UUI. The insertion process takes place in a minimally invasive procedure requiring 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.”
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Medtronic says Altaviva comes in at approximately half the length of a stick of chewing gum. It sits slightly below the skin and above the fascia to send electrical impulses to the tibial nerve. This process helps restore communication between the bladder and the brain to regulate bladder control.
The device includes a 15-year battery lifespan under expected therapy settings and delivers therapy automatically. It requires no daily intervention or manual adjustments from the patient. Recharging takes up to 30 minutes when using the default speed. This eliminates the need for daily at-home charging equipment.
According to Medtronic, nearly 16 million American adults deal with urge urinary incontinence. The condition, marked by sudden urges to urinate, often followed by involuntary leaks, can disrupt 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, part of the Neuroscience Portfolio at Medtronic. “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.”
