Medtronic Wins FDA Approval for Altaviva Neuromodulation Device
Medtronic has received U.S. Food and Drug Administration (FDA) approval for its Altaviva device, a minimally invasive implantable tibial neuromodulation therapy designed to treat urge urinary incontinence. The device is placed near the ankle during a short outpatient procedure, where it delivers electrical stimulation to the tibial nerve to help regulate bladder control.
Urge urinary incontinence affects an estimated 16 million people in the United States, yet treatment uptake remains low due to limited options and concerns over invasiveness. Altaviva introduces a new approach by allowing patients to leave the procedure with therapy already activated, eliminating the need for daily device management.
About half the size of a chewing gum stick, the device is designed for long-term use with a projected 15-year battery life and short recharging cycles. It is also MRI-compatible, supporting continued access to medical imaging when needed. Clinicians involved in pivotal studies noted the therapy’s potential to improve quality of life while reducing the burden of current treatment strategies.
With this approval, Medtronic becomes the only company offering a full portfolio of neuromodulation therapies for bladder control, further extending its leadership in the field. The company plans to discuss the market introduction of Altaviva during an investor webcast on October 9, 2025.
