FDA clears Revi Extend implant for urgency urinary incontinence

The FDA has granted 510(k) clearance to Revi Extend, a next-generation implantable tibial neuromodulation (ITNM) device for urgency urinary incontinence (UUI) that is intended to extend the implant longevity from 10 years to 15 years.¹

According to the company, the updated implant is expected to be introduced through a limited US launch in the fourth quarter of 2026.

The clearance builds on the existing Revi System, which received initial FDA clearance in August 2023. Revi Extend maintains the same therapeutic platform while increasing the intended implant life to 15 years.

"FDA clearance of our next-generation implant reflects our continued commitment to meaningful innovation for patients and physicians," said Kerry Nelson, CEO of BlueWind Medical, in the news release.¹ "Extending implant durability coupled with our remotely enabled software advancements allows patients to receive the latest therapy innovations for 15 years into the future.”

Data on the Revi System

Clinical evidence supporting the Revi platform comes primarily from the multicenter, prospective, single-arm OASIS pivotal study (NCT03596671), which enrolled 151 women with urgency urinary incontinence.² Data showed sustained symptom improvement and an acceptable long-term safety profile in women with UUI.

Related: Revi implantable tibial neuromodulation shows durable 3-year response rates in UUI

Of the 151 implanted participants, 140 (93%) completed the 12-month study. Among these, 119 enrolled in the extension study, and 90 completed the 36-month evaluation.

At 3 years, 79% of evaluable participants achieved at least a 50% reduction in UUI episodes based on 3-day voiding diaries, while 63% experienced at least a 75% reduction in episodes. Therapeutic response remained stable over time, with responder rates of 78% at 6 months and 79% at 36 months. Additionally, 95% of respondents reported satisfaction with therapy, and 82% described themselves as "much better" or "very much better" on the Patient Global Impression of Improvement scale. No device-related or procedure-related serious adverse events were reported through 3 years.

About the Revi System

The Revi System consists of a small implant placed adjacent to the posterior tibial nerve near the ankle during an outpatient procedure performed under local anesthesia. Therapy is delivered through an external wearable controller that powers the implant, eliminating the need for an implanted battery or lead extensions. Patients self-administer stimulation sessions once daily at home.

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