tibial nerve

AUA/SUFU Guideline on the Treatment of Overactive Bladder Allows Access to Revi™ System Earlier in Treatment Journey

BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the developer of ReviTM, a patient-centric solution for urge urinary incontinence (UUI), announced today that the Revi System, a minimally invasive therapy, is now included in the American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) clinical practice guideline on the diagnosis and treatment of idiopathic overactive bladder (OAB). The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI. First, the guidelines were updated to include iTNM as an acceptable minimally invasive therapy.  In addition, the revised guidelines shift away from traditional step therapy approaches, allowing physicians and patients to bypass behavioral and pharmacotherapy before considering minimally invasive therapies, including Revi.  Read more.

Source: PRNewswire, April 29, 2024

nurse and patient

Published Data Demonstrate Excellent Safety and Efficacy and Reinforce Patient Satisfaction with Revi™ System in the Treatment of Urge Urinary Incontinence

BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the developer of ReviTM, a patient-centric solution for urge urinary incontinence (UUI), today announced that the peer-reviewed results from the OASIS pivotal trial were published in the Journal of Neurourology and Urodynamics (NAU). OASIS, a prospective, multicenter, single-arm, open-label clinical study of 151 women, was designed to demonstrate the safety and efficacy of Revi in reducing symptoms of overactive bladder (OAB).  The trial results demonstrate a statistically significant improvement with a 78.4% clinical success rate as defined by at least a 50% reduction in UUI at 12 months in the intention to treat (ITT) analysis (p<.0001). Read more.

Source: PRNewswire, April 23, 2024

product approval introduction

BlueWind Medical’s Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence

BlueWind Medical, Ltd. today announced that the US Food and Drug Administration (FDA) granted a De Novo marketing request for the Revi System, a transformative tibial neuromodulation therapy for the treatment of the symptoms of urgency incontinence alone or in combination with urinary urgency. Physicians should follow clinical guidelines as applicable and should use their discretion to determine if Revi can be used before patients fail or not tolerate more conservative therapy. The De Novo grant is for men and women with urge urinary incontinence (UUI) and was based on results from the OASIS pivotal trial, in which Revi demonstrated statistically significant improvement in the reduction of symptoms of UUI compared to baseline and a favorable safety profile. Read more.

Source: PRNewswire, August 17, 2023