Medtronic has received FDA approval for the Altaviva device, an implantable tibial neuromodulation (ITNM) therapy that's inserted near the ankle and designed to treat urge urinary incontinence.
Patients who receive an Altaviva device return home with therapy activated. The device is inserted near the ankle during a minimally invasive procedure that doesn't require sedation or imaging. Approximately half the length of a stick of chewing gum, the Altaviva device sits slightly below the skin and above the fascia. It sends electrical impulses to the tibial nerve, helping restore communication between the bladder and the brain to regulate bladder control.
"It's an honor to bring the Altaviva device to market," said Emily Elswick, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. "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 Altaviva device is designed to have a 15-year battery lifespan under expected therapy settings and delivers therapy automatically, requiring no daily intervention or manual adjustments from the patient. Recharging will take up to 30 minutes when using the default recharging speed, eliminating the need for daily at-home charging equipment. Designed for real-life needs, the Altaviva device is MRI-compatible, providing patients with peace 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."
For over 30 years, Medtronic neuromodulation devices have improved the lives of people with bladder control symptoms. With the introduction of the Altaviva device, Medtronic becomes the only company with a full portfolio of neuromodulation therapies for this condition.
