Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence.

Purpose: The BlueWind Medical Device, Revi, is a novel implantable tibial neuromodulation system powered by an external, battery-operated wearable that facilitates individually tailored stimulation to provide treatment for urgency urinary incontinence (ie, overactive bladder wet). The Revi System is the first Food and Drug Administration-cleared implantable neuromodulation device which can be used without prior failure with more conservative treatment options. Two-year follow-up results of the OASIS study are presented.

A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

Background: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic.