Amber Therapeutics Announces Successful First-in-human Implants of Amber-UI: An Intelligent, Closed-loop Bioelectrical Therapy for Urge and Mixed Urinary Incontinence

Amber Therapeutics (‘Amber’ or the ‘Company’), a University of Oxford spinout developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces that the first participants have been implanted with Amber-UI, the Company’s proprietary therapy for urge and mixed urinary incontinence (UI). Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for UI, which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure. Read more.

Source: PRNewswire, January 24, 2023

UroMems Initiates First-in-Human Study of Its Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing breakthrough, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-in-human implant of the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) investigational device to treat SUI. This initial clinical study is a key milestone in the development of UroActive. Read more.

Source: PRNewswire, November 29, 2022

Neuspera Medical® Announces First Successful Implant of the Nuvella™ System in the Second Phase of Its SANS-UUI IDE Clinical Trial

Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced the first patient successfully implanted with the Nuvella™ system in its pivotal clinical trial (SANS-UUI). The procedure was performed by Dr. Jodi Michaels of Minnesota Urology, St. Paul, MN. The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms. Read more.

Source: PRNewsire, October 10, 2022

Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has approved its newly developed, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS). Read more.

Source: Business Wire, March 7, 2022

Axonics® Submits Pivotal Clinical Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of pivotal clinical data from the ARTISAN-SNM pivotal clinical study designed to gain marketing approval from the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System¹. The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption (“IDE”) to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction. Read more.

Source: Business Wire, February 26, 2019

Tiny, Implantable Device Uses Light to Treat Bladder Problems

A team of neuroscientists and engineers has developed a tiny, implantable device that has potential to help people with bladder problems bypass the need for medication or electronic stimulators. The team—from Washington University School of Medicine in St. Louis, the University of Illinois at Urbana-Champaign, and the Feinberg School of Medicine at Northwestern University in Chicago—created a soft, implantable device that can detect overactivity in the bladder and then use light from tiny, biointegrated LEDs to tamp down the urge to urinate. The device works in laboratory rats and one day may help people who suffer incontinence or frequently feel the need to urinate. The new strategy is outlined in an article published Jan. 2 in the journal Nature. Read more.

Source: Medical Xpress, January 2, 2019

InterStim Incontinence and Bladder Control Implant Now Controlled via App

Medtronic won FDA approval to introduce the InterStim smart programmer to control the company’s InterStim neurostimulation system used to manage overactive bladder, bowel incontinence, and some types of urinary retention. The InterStim system delivers sacral neuromodulation therapy via an implant that looks similar to a cardiac pacemaker. Read more.

Medgadget, December 17, 2018

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

Axonics Sacral Neuromodulation System Receives Marketing Approval

Axonics Modulation Technologies, Inc. announced today that it received a Homologation d’un instrument médical (medical device approval) for the first rechargeable Sacral Neuromodulation (r-SNM™) System® to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention. The Health Canada license confirms that the Axonics^® product meets all of the Canadian Medical Devices Regulations, Section 36, for Active Implantable Medical Devices and enables Axonics to market its r-SNM System throughout Canada. Read more.

Source: Yahoo! Finance, January 5, 2017

Sacral Nerve Stimulation for Incontinence

Sacral nerve stimulation involves the placement of an implant to stimulate the sacral nerve.

Sacral nerve stimulation (SNS), also called sacral neuromodulation, involves surgical implantation of a device that sends a low-voltage electrical current to the sacral nerve. The sacral nerve is located at the base of the spine that affects the bladder, bowel, and pelvic floor. The implant stimulates the sacral nerve and to alleviate fecal and/or urinary incontinence. A hand-held device is used to stop the contraction of your sphincter muscles when you need to empty your bowels.Continue reading→