The tibial neuromodulation therapy is designed with a 15-year battery life and is MRI-compatible.
Medtronic has received Food and Drug Administration (FDA) approval for its Altaviva device, a minimally invasive implantable tibial neuromodulation (ITNM) therapy designed to treat urge urinary incontinence.
Bladder control problems affect an estimated one in six US adults, with nearly 16 million experiencing urge urinary incontinence, a common symptom of overactive bladder. The condition is characterized by a sudden, intense urge to urinate followed by involuntary leaks.
The Altaviva device is inserted near the ankle in a procedure that does not require sedation or imaging. It is designed to send electrical impulses to the tibial nerve, which helps restore communication between the bladder and the brain to regulate bladder control.
“The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” says Kevin Benson, MD, urogynecologist at Sanford Health and investigator for the device’s pivotal study, in a release.
Device Technology and Specifications
According to the company, the device is approximately half the length of a stick of chewing gum and is implanted just below the skin. Patients can return home with the therapy activated. The device is designed to have a 15-year battery lifespan under expected therapy settings and delivers therapy automatically, requiring no daily manual adjustments from the patient.
Recharging is expected to take up to 30 minutes, eliminating the need for daily at-home charging equipment. The Altaviva device is also MRI-compatible, allowing patients to undergo planned or unexpected medical imaging.
“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,” says Emily Elswick, president of the pelvic health business at Medtronic, in a release. “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.”
Photo caption: Altaviva
Photo credit: Medtronic
