Articles similar to: tibial nerve stimulation

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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

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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

Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

Valencia Technologies Corporation, a privately held company, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable safety profile demonstrated in the eCoin® pivotal trial. The company also announced the publication of these results in the Journal of Urology®, the official journal of the American Urological Association. Read more.

Source: PRNewswire, March 2, 2022

product approval introduction

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

product approval introduction

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

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StimGuard Announces Corporate Name Change to Micron Medical and Appointment of CEO as part of Expansive Executive Management Team

StimGuard LLC, a privately-held medical device company engaged in the development, manufacture and pre-commercialization of innovative wireless, injectable electroceutical device solutions for urological conditions, today announced that it is changing its corporate name to Micron Medical Corporation. In addition, effective immediately, Stephen Deitsch has been appointed as Chief Executive Officer (CEO) and will join the Company’s board of directors. Co-founder Laura Tyler Perryman will now assume the role of Chief Operating Officer (COO) in order to focus on product development, regulatory and clinical affairs efforts.  Read more.

Source: StreetInsider, April 3, 2020

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The Journal of Urology Publishes Valencia’s Excellent Feasibility Data on eCoin™ for Overactive Bladder

Last week, The Journal of Urology published the feasibility data of Valencia Technologies’ (“Valencia“) eCoin™ device indicated for treatment of overactive bladder.  The manuscript, “Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence,” details the design of Valencia’s 46 patient study and the study’s excellent clinical results.  The manuscript has an embargo date of February 15, 2019. Implanted in a 20-minute office procedure across seven clinical centers in the United States and New Zealand, the coin-sized and shaped tibial nerve stimulator is distinctly simple to implant in stark contrast to a highly invasive and operator dependent therapy called sacral nerve stimulation. An author of the eCoin™ publication, Dr. Vincent Lucente, concludes, “I believe tibial nerve stimulation with eCoin™ will become the therapy of choice for patients after medications are tried. These early results clearly show a better therapy is on the horizon for patients with urinary incontinence.” Read more.

Source: PRNewswire, November 1, 2018

tibial nerve

StimGuard Launches Head-to-Head Trial Against Medtronic’s InterStim

StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT).  Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve. Read more.

Source: Massdevice, March 1, 2018