Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI.
Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct in men and bladder neck in women. It’s controlled by a patient’s activity without the need for manual adjustments. This provides patients ease of use and better quality of life compared to other options. The company previously had positive early feasibility data in a study of six men, but this marks the first-ever female implant.
UroMems said the milestone indicates “a new era” for women suffering from SUI. It could also signal a transition for surgeons treating SUI, not only in France (where the female patient received the implant) but across Europe and the U.S.
The primary outcome measures included the successful device activation and rate of explants and revisions at six months. UroMems says the first female patient not only met the primary endpoints by remaining revision-free but also reported restored social continence. The company reports “extremely positive” follow-up on secondary measures, such as leak rate values.
“We are elated to reach this critical achievement contributing to the demonstration of the feasibility of the UroActive System to successfully treat women suffering from debilitating SUI,” said Hamid Lamraoui, UroMems CEO and co-founder. “The compelling results of this first-in-female implant show the high potential of our technology, bringing us one step closer to delivering on the massive unmet need for women and physicians desperately seeking a better SUI treatment option.”