Therapy Areas: Devices
Medtronic secures FDA approval for Altaviva implantable device for treating urge urinary incontinence
19 September 2025 -

Ireland-based healthcare technology company Medtronic plc (NYSE:MDT) announced on Friday that the US Food and Drug Administration has approved its Altaviva implantable tibial neuromodulation (ITNM) device, expanding treatment options for patients with urge urinary incontinence.

The minimally invasive therapy is implanted near the ankle and designed to restore communication between the bladder and brain through electrical stimulation of the tibial nerve.

Urge urinary incontinence affects nearly 16 million Americans and is a common symptom of overactive bladder. Despite the prevalence of bladder control issues, only a fraction of patients seek medical advice, contributing to significant personal and societal costs.

Medtronic says that the Altaviva device is the first implantable tibial therapy for urge urinary incontinence that is activated immediately after the procedure. Roughly half the length of a stick of chewing gum, it is placed under the skin without the need for sedation or imaging.

Key features include a 15-year battery lifespan, 30-minute recharging sessions, and MRI compatibility. Patients do not need to manage daily intervention or manual therapy adjustments, offering a simplified treatment experience and an alternative to absorbency products.

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