Medtronic has secured U.S. Food and Drug Administration (FDA) approval for the Altaviva device, a minimally invasive implantable tibial neuromodulation (ITNM) therapy for urinary urge incontinence (UUI).

Patients receiving Altaviva return home with therapy activated, which the company said is a first among implantable tibial devices for UUI. The device is inserted near the ankle in a minimally invasive procedure that doesn’t need sedation or imaging.

Altaviva is about half the length of a stick of chewing gum and sits slightly below the skin and above the fascia. It sends electrical impulses to the tibial nerve to help restore communication between the bladder and brain to regulate bladder control.

“It’s an honor to bring the Altaviva device to market,” said Emily Elswick, president of Medtronic’s Pelvic Health business. “For too long, society has told people it is normal to eventually lose bladder control. We say, “enough”. What is common does not mean it is normal. The Altaviva device is designed to provide a simple and effective experience to treat urge urinary incontinence, empowering patients with a technology that supports them in their daily lives and opens the door to renewed hope and improved quality of life.”

The device was designed to have a 15-year battery lifespan under expected therapy settings. It delivers therapy automatically and requires no daily intervention or manual adjustments from the patient. Recharging takes up to half an hour when using default recharging speed.

Altaviva is MRI-compatible, allowing patients piece of mind for planned or unexpected medical imaging.

“Too many people silently struggle with the challenges of urgency and loss of bladder control, often believing that relying on diapers or pads is their only option,” said Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio. “The Altaviva device represents a transformative milestone and ushers in a new bladder control therapy with advanced features. Medtronic has earned its position as the global leader in neuromodulation by consistently pushing the boundaries of innovation, and this FDA approval underscores our unwavering commitment to delivering therapies that truly change lives.”