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
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ― the next generation of the InterStim™ portfolio’s recharge-free device – and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim™ Micro device. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. Read more.
Source: PRNewswire, February 22, 2022
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
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 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