Altaviva, an implantable tibial neuromodulation (ITNM) device, is inserted near the ankle and designed to treat urge urinary incontinence (UUI).
Patients who receive an Altaviva device return home with therapy activated. Medtronic says this marks a first among implantable tibial devices for treating UUI. The insertion process takes place in a minimally invasive procedure requiring no sedation or imaging.
Medtronic won FDA approval for Altaviva in September 2025, announcing the first commercial cases a week later.
On the company’s recent third-quarter earnings call, CEO Geoff Martha said the medtech giant has seen “great early interest and feedback from both physicians and patients” for Altaviva.
The company said TITAN 2 imposed the “strictest requirements for prior drug failure and drug discontinuation” among ITNM clinical trials. It also included patients with various BMI and comorbidities.
At 12 months, the study met all primary and secondary endpoints with sustained improvements over the course of the study. Among patients with 100% UUI reduction, approximately 20% had no UUI episodes at all at 12 months. Additionally, 80% of patients reported improved conditions, and 61% maintained a greater than or equal to than 50% reduction in daily UUI episodes.
“The TITAN 2 12-month data show that the Altaviva implantable tibial neuromodulation device can provide meaningful, durable symptom improvement for patients with urge urinary incontinence who have not responded to traditional therapies,” said Dr. Keith Xavier of Urology Partners in North Texas. “Notably, these outcomes were achieved without the use of concurrent medications, and almost 30% of the study participants had tried previous advanced overactive bladder options, highlighting the potential for sustained symptom relief among the real-world patient population.”
