Medtronic has received FDA approval for a new implant aimed at improving bladder control, with a small device placed near the ankle designed to be more convenient and accessible.
Compared to other neuromodulation devices for treating urge urinary incontinence, which are typically located in the lower back near the tailbone, the Altaviva system can be inserted with a minimally invasive procedure without the need for sedation or imaging.
The company described the implant as about half the length of a stick of chewing gum, slipped just below the skin. It can be recharged in less than 30 minutes and is slated to have a 15-year lifespan. The device automatically delivers pulses of electric stimulation to the tibial nerve that runs the length of the leg, to help restore communication between the bladder and the brain.
“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,” Brett Wall, president of Medtronic’s neuroscience portfolio, said in a statement. “The Altaviva device represents a transformative milestone and ushers in a new bladder control therapy with advanced features.”
Following years in development, Altaviva will join the company’s decades-old line of InterStim sacral nerve modulation devices, which includes rechargeable and non-rechargeable implants also designed to aid in bowel incontinence.
Medtronic also markets the Nuro system, with its external, needle-based device to stimulate the tibial nerve, which is performed in a series of 30-minute office appointments. The company estimates that about 16 million people in the U.S. live with urinary urges and involuntary leaks, though only about a quarter of them have discussed these issues with a doctor.
“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,” said Medtronic’s pelvic health president, Emily Elswick. “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.”