The US Food and Drug Administration (FDA) has approved Medtronic鈥檚 Altaviva device, intended for the treatment of urge urinary incontinence.
This implantable tibial neuromodulation (ITNM) device allows its recipients to leave the clinic with the therapy already functioning, which the company notes is the first among similar implantable tibial devices for this condition.
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Implantation of the device is minimally invasive, requiring no sedation or imaging, and is conducted near the ankle.
Slightly larger than half the size of a standard stick of chewing gum, the device is placed just beneath the skin and over the fascia.
It functions by transmitting electrical impulses to the tibial nerve. These impulses aim to improve the communication between the bladder and the brain, thereby regulating bladder control.
Designed with longevity in mind, the device has a 15-year battery life expectancy at typical therapy settings.
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By GlobalDataIt operates automatically, sparing patients the hassle of daily manual adjustments or interventions.
When recharging is required, it can be completed in as little as 30 minutes using the default speed, thus forgoing the need for daily charging equipment at home, the company said.
Furthermore, the device is compatible with magnetic resonance imaging (MRI), allowing individuals to undergo medical imaging without concerns.
Medtronic neuroscience portfolio president and executive vice-president Brett Wall said: “Too many people silently struggle with the challenges of urgency and loss of bladder control, often believing that relying on diapers or pads聽is their only option.
“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.”
Recently, Medtronic and the Manchester University UK National Health Service (NHS) Foundation Trust (MFT) signed an agreement to jointly develop healthcare technologies, including robotic surgery and AI-related initiatives.
