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

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 30^th. Read more.

Source: PRNewswire, May 1, 2023

Medtronic Kicks Off Pivotal Study of Tibial Neuromodulation Implant for Overactive Bladder

After receiving an FDA approval last month in bladder and bowel incontinence for its neuromodulation device implanted in the lower back, Medtronic isn’t resting on its laurels. It has begun a clinical trial of a similar system placed near the ankle, which the company described as a more convenient option that may make the therapy available to more people. The medtech giant announced that its first patients have received implants in the pivotal study, with neurostimulators that tap into the posterior tibial nerve running up the back of the leg, to transmit electrical pulses that aim to help regulate an overactive bladder. Read more.

Source: Fierce Biotech, March 25, 2022

Tibial Nerve Stimulator Is Safe, Effective, and Durable, 12-month Data Indicate

A nickel-sized tibial nerve stimulator offers overactive bladder (OAB) patients with urgency urinary incontinence long-term outcomes comparable to other treatment options, including percutaneous tibial nerve stimulation. Findings of a study published in Urology¹ imply OAB treatment with the investigational eCoin (Valencia Technologies Corp) device is safe and achieves a durable response, says the study’s lead author, urologist Peter Gilling, MD, of Tauranga Urology Research Ltd, Tauranga, New Zealand. Read more.

Source: Urology Times, July 15, 2021

FDA Authorizes Study Exploring Novel Device for Bladder Incontinence

The FDA has approved the launch of an investigational device exemption trial exploring a novel implantable tibial neuromodulation (TNM) device designed to relieve symptoms of bladder incontinence. The trial, known as the TITAN 1 Feasibility Study, is a multicenter, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. They will be followed for 12 months to assess the feasibility of the product. Enrollment for the trial is expected to commence in May. Medtronic currently offers several products for bladder control, including the InterStim sacral neuromodulation systems and the NURO percutaneous tibial neuromodulation (PTNM). Read more.

Source: Urology Times, April 27, 2021