nerve cells

Implantable Tibial Nerve Stimulation added as Treatment Option within AUA/SUFU 2024 OAB Guideline

Valencia Technologies is pleased to announce that implantable tibial nerve stimulation (ITNS) has been acknowledged as a minimally invasive OAB treatment option in the recently updated 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 (2024). The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB. The eCoin ITNS system commercialized in March 2022 has now been used to treat over 1,100 patients in the United States. This highlights the significant need for evolutionary treatment options to address the growing burden of a largely underserved OAB population. Read more.

Source: PRNewswire, May 2, 2024

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

clinical medical

Multi-center Study Published in Urology Confirms Efficacy and Safety of Avation Medical’s Noninvasive Vivally® System for OAB

Avation Medical, Inc., an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions, today announced the publication of safety and efficacy results from a  multi-center study, “FREEOAB”, for its novel Vivally System in Urology, a leading, peer–reviewed journal for urologists.  “The Vivally System represents a significant advancement in bladder control therapy as a non-invasive, patient-centered therapy providing patients with effective treatment, performed in the home, without the need for surgery or drugs,” said Dr. Colin Goudelocke, Principal Investigator for the FREEOAB Study.  “In our study, significant reductions in symptom burden were observed at 12 weeks which, notably, persisted out to 12 months, even with a reduction in frequency of therapy sessions.” Read more.

Source: PRNewswire, November 15, 2023

Acupuncture

Acupuncture for Women With Overactive Bladder

The most common symptom of an overactive bladder is a sudden, uncontrolled need or urge to urinate; followed by the need to urinate excessively throughout the day and night, independent of fluid intake. In women, causes of overactive bladder are varied, but the common consequence, beyond the physical manifestations, are frustration and embarrassment.  While medications designed to relax the bladder remain a frontline treatment option, research continues to show the potential of nonpharmaceutical options – including acupuncture. Case in point: a 2023 research review that concludes acupuncture is effective and safe for treating overactive bladder. Read more.

Source: Acupunture Today, May/June 2023

Elitone by Elidah

Women’s Health Leader Elidah Launches Game-changing ELITONE URGE Device To Treat Overactive Bladder

Providing the same relief for overactive bladder (OAB) that they’ve become known for in the stress urinary incontinence arena, MedTech Elidah is excited to introduce their newest product, ELITONE URGE (https://elitone.com/products/), the first and only non-intrusive treatment for urge incontinence. This latest device, a natural successor to ELITONE, is specified to treat urgency bladder leaks that afflict 33 million women in the United States alone. ELITONE URGE is an external, non-implanted muscle stimulator that outputs signals to calm the muscles and nerves that cause urgency or OAB leaks. The patented design maximizes comfort and efficacy, while being discreet and wearable under clothes, for the perfect urge incontinence therapy. Read more.

Source: Globe Newswire, May 2, 2023

meeting conference

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session (LBA01-05) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30th. Read more.

Source: PRNewswire, May 1, 2023

business buildings

Avation Medical Announces US FDA 510(k) Clearance for The Vivally® System

Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, today announced that its Vivally System received US Food and Drug Administration (FDA) 510(k) clearance. Vivally is a non-invasive, bladder control therapy device and mobile application to treat patients with the conditions of urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome, without the need for surgery, drugs, or needle-electrodes. The Vivally System is the only closed-loop, non-invasive neuromodulation system for bladder control cleared for sale in the United States. Closed-loop control objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session. Read more.

Source: PRNewswire, April 11, 2023