Battery-Free Device Implanted Through Minimally-Invasive Procedure Treats Bladder Leaks

Urinary urgency incontinence (UUI), a chronic and often debilitating condition, affects millions and can greatly disrupt daily life. Current treatments aimed at improving bladder control, such as medications and surgical interventions, often come with drawbacks, including side effects or limitations Now, an innovative Implantable Tibial NeuroModulation (iTNM) device offers an exciting new treatment option that could provide relief for patients with UUI.

The Revi Implant, developed by BlueWind Medical (Park City, UT, USA), is a small, battery-free device implanted near the ankle during a minimally invasive outpatient procedure under local anesthesia. Once implanted, the device stimulates the posterior tibial nerve to help alleviate UUI symptoms. Activation of the Revi Implant is simple: a lightweight wireless wearable is placed around the ankle once or twice a day, allowing patients to receive stimulation at their convenience. The battery-free design allows the Revi Implant to be miniaturized, measuring just 3 cm in length and 3 mm in diameter, which eliminates the need for future surgeries to address issues such as battery depletion, lead fractures, or migration.

Last year, the U.S. Food and Drug Administration (FDA) granted De Novo marketing authorization for the Revi System for men and women suffering from UUI. This approval was based on results from the OASIS pivotal trial, where Revi showed statistically significant symptom reduction and a favorable safety profile compared to baseline. Revi stands out as the only neuromodulation therapy that gives physicians the flexibility to decide if patients should try more conservative treatments before using the Revi System, rather than advising them to undergo "step-therapy."

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