BlueWind Medical’s Revi Extend, the company’s next-generation urge urinary incontinence (UUI) treatment that extends the implant’s lifespan to 15 years, has secured US Food and Drug Administration (FDA) clearance.
The Utah-based company’s implantable tibial neuromodulation (ITNM) system gets implanted near the ankle during a single outpatient procedure, delivering targeted stimulation to the posterior tibial nerve to alleviate UUI symptoms.
FDA clearance for Revi Extend, which also features a wearable control that allows patients to personalise their therapy, follows a previous clearance for an updated version of BlueWind’s Revi system in December 2025 that features a simplified three-button interface intended to make long-term therapy easier to manage.
Overactive bladder (OAB), or the frequent urge for an individual to empty their bladder, affects an estimated 33 million people in the US, with around half of those struggling with UUI, wherein bladder leakage occurs, according to the National Association for Continence (NAFC).
With FDA clearance in hand, BlueWind plans to initiate a limited US market launch of Revi Extend in Q4 2026.
BlueWind’s CEO, Kerry Nelson, commented: "FDA clearance of our next-generation implant reflects our continued commitment to meaningful innovation for patients and physicians.
"Extending implant durability coupled with our remotely enabled software advancements allows patients to receive the latest therapy innovations for fifteen years into the future.”
BlueWind’s latest clearance follows its completion of a $47.8m fundraise in May 2026 that it is applying towards expanding commercialisation of its UUI treatment range. The company’s tibial nerve stimulation approach to UUI represents just one of the neuromodulation methodologies gaining traction in the urology space for the treatment of UUI and other bladder dysfunction, including OAB and stress urinary incontinence (SUI).
According to a report by GlobalData, the global neurological devices market will reach a valuation of $20.9bn by 2033, up from $12.5bn in 2023.
Boston Scientific is one of the biggest players in the medtech industry set about growing its urology portfolio. Boston acquired Valencia Technologies in January 2026, giving the medtech giant an implantable tibial nerve stimulation (ITNS) system for UUI treatment.
Meanwhile, Neuspera, which has taken a different approach to UUI with its integrated sacral neuromodulation system (iSNM) that treats the condition by targeting the sacral nerve, secured FDA approval in June 2025.
