Intro to REVI EXTEND IMPLANT (Not a sponsor)

<p>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&#39;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. </p><p>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</p><p>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</p><p>3. 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</p><p><br></p>