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

Botox injection overactive bladder

Sacral Neuromodulation, Botulinum Show Equal Efficacy

In patients with refractory urgency urinary incontinence (UUI), sacral neuromodulation (InterStim) and onabotulinumtoxinA (Botox) produce similar reductions in mean daily UUI episodes, according to 24-month follow-up data on patients treated in a randomized trial.  Investigators in the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation versus BoTulinum Toxin Assessment) trial in 2016 reported that botulinum toxin at 6 months of treatment resulted in a “small daily improvement in UUI episodes” that was statistically significant (JAMA 2016; 316:1366–74).  Now, in long-term follow-up data on ROSETTA, NIH investigators reported at the International Continence Society annual meeting in Florence, Italy that the two treatments provide similar reductions in mean daily UUI episodes at 24 months. However, botulinum toxin treatment was more likely to provide complete resolution of episodes 6 months after treatment, and it was associated with higher patient satisfaction and treatment endorsement ratings over the 24 months, reported first author Christopher J. Chermansky, MD, assistant professor of urology at the University of Pittsburgh School of Medicine. Read more.

Source: Urology Times, November 14, 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