Intro to REVI EXTEND IMPLANT (Not a sponsor)

Urge urinary incontinence (UUI) places a significant emotional and physical burden on women affected. Sacral neuromodulation has been and remains a well-established implant-based therapy for UUI. The concept originated in the early 1970s from sacral anterior root stimulation research for neurogenic bladder, with human clinical trials beginning in 1982. Medtronic's InterStim device received FDA approval in 1997 for UUI, and in 1999 for urgency-frequency and nonobstructive urinary retention. This was a game changer for affected women. Now, as of August 5, 2026, the FDA has granted 510(k) clearance for a new, less invasive neuromodulation implant- placed in the ANKLE. This is the Revi Extend Implant system (BlueWind Medical). What was the phase 3 data on this? What does the “wearable controller device” look like? Listen in for details.

1. Lukacz ES, Santiago-Lastra Y, Albo ME, Brubaker L. Urinary Incontinence in Women: A Review. JAMA. 2017;318(16):1592–1604. doi:10.1001/jama.2017.12137

2. Amundsen CL, Sutherland SE, Heesakkers JPFA, et al. Three-year efficacy and safety of Revi implantable tibial neuromodulation from the pivotal OASIS study. J Urol. 2026;216(2):219-229. doi:10.1097/JU.0000000000005062

BlueWind Medical receives FDA 510(k) clearance for Revi Extend implant. News release. BlueWind Medical Ltd. August 5, 2026. Accessed August 5, 2026. https://www.businesswire.com/news/home/20260805290667/en/BlueWind-Medical-Receives-FDA-510k-Clearance-for-Revi-Extend-Implant