FDA approves Altaviva device for urge urinary incontinence

Medtronic announced on September 19, 2025, that the FDA had approved its Altaviva device, an implantable tibial neuromodulation therapy for patients with urge urinary incontinence.¹

The Altaviva device is inserted near the ankle during a minimally invasive procedure without the need for sedation or imaging. Patients can return home with therapy activated, which Medtronic notes is “a first among implantable tibial devices for urge urinary incontinence.”

"The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential [adverse] effects when considering treatment options," said Kevin Benson, MD, a urogynecologist at Sanford Health and investigator for the Altaviva device pivotal study (TITAN 2), in a news release from Medtronic.¹ "I'm excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people."

The Altaviva device is designed to have a 15-year battery life span under normal battery settings. Recharging will take up to 30 minutes when using the default recharging speed. The device is also MRI compatible.

The approval of the Altaviva device is supported by data from the pivotal TITAN 2 trial (NCT05226286), which enrolled 188 adult patients with urge urinary incontinence across 29 clinical trial sites in the US.² Patients enrolled in the prospective study needed to have a diagnosis of urge urinary incontinence for at least 6 months and failed or were not candidates for conservative therapies.

The primary outcome measure was the proportion of patients who experienced at least a 50% reduction in urge urinary incontinence episodes at 6 months following device implant. Secondary end points included change in urinary frequency episodes (voids/day) from baseline to 6 months, change in urinary urgency based on the urgency perception scale at 6 months, and change in overactive bladder quality-of-life questionnaire health-related quality of life (OAB-q-HRQL) total score at 6 months.

This study followed positive findings from the TITAN 1 feasibility study (NCT04873271), which successfully implanted the device in 20 patients. All patients demonstrated motor and/or sensory response to stimulation intraoperatively and postoperatively and at the 7-day follow-up visit. Further, 18 of 19 patients demonstrated a motor and/or sensory response at the 14-day follow-up visit; the assessment was not performed in 1 patient.

In total, there were 5 device-, procedure-, and/or therapy-related adverse events among 3 patients. This included 1 serious adverse event (wound infection), which led to device explant at 6 weeks following implant.

"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," said Brett Wall, executive vice president and president of the Medtronic Neuroscience Portfolio, in the news release.¹ "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."

REFERENCES

1. Medtronic secures FDA approval for the Altaviva device, a simple experience for treating urge urinary incontinence. News release. Medtronic plc. September 19, 2025. Accessed September 19, 2025. https://news.medtronic.com/2025-09-19-Medtronic-secures-FDA-approval-for-the-Altaviva-TM-device,-a-simple-experience-for-treating-urge-urinary-incontinence

2. Lee UJ, Xavier K, Benson K, et al. Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device. Contemp Clin Trials Commun. 2023:35:101198. doi:10.1016/j.conctc.2023.101198