doctor and patient

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

medical research

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

business buildings

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

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

Health Canada logo

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

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

Artificial Sphincter Surgery for Urinary Incontinence

male artificial sphincter

Drawing of  a male artificial sphincter to control urination.

Everyone has a pelvic floor: it is a hammock of muscles that lies in your pelvis, supporting the organs (bowel, bladder, and – in women – the uterus) in that area and keeping them in the correct place. In your pelvic floor are a few muscles that are called “sphincters”. There is an internal and external sphincter surrounding the urethra (the tube that takes urine from the bladder out of your body). These urinary sphincters naturally contract around the urethra and keep urine inside your body until you relax the sphincters at a socially-acceptable time (generally when you’re using a toilet). As the urge to urinate increases, you can voluntarily increase the contraction of your sphincters to gain more control.Continue reading

Artificial Sphincter Surgery for Bowel Incontinence

external sphincter muscle squeezing

This shows the external sphincter muscle properly squeezing and keeping fecal matter inside until he proper time.

Everyone has a pelvic floor: it is a hammock of muscles that lies in your pelvis, supporting your internal organs in that area (bowel, bladder, and – in women – the uterus) and keeping them in the correct place. In your pelvic floor are a few muscles that are called “sphincters”.  There is an internal and external sphincter surrounding the anus. These anal sphincter muscles naturally contract around the rectum and keep the fecal matter inside your body until you relax the sphincters at a socially-acceptable time (generally when you’re using a toilet).  As the urge to defecate increases, you can contract (or squeeze) your sphincters to gain more control.  When you cannot control these sphincter muscles, bowel incontinence (also called accidental bowel leakage or fecal incontinence) may happen.

Surgery to implant an artificial sphincter involves placing an inflatable sphincter around the anus. A pump (placed inside the body in the labia or scrotum) is used to deflate the device, allowing fecal matter to pass through at the appropriate time. The device automatically refills after ten minutes, once again closing off the rectum.Continue reading