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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
Axonics, based in Irvine, California, won European regulatory approval for MRI conditional labeling for its sacral neuromodulation (SNM) system for treatment of overactive bladder, urinary retention, and fecal incontinence. The Axonics SNM system is now compatible, given certain precautions, with 1.5 Tesla and 3 Tesla MRI scanners. It is the only SNM system cleared in Europe with such labeling. The implant is rechargeable, and so can be used for much longer periods than similar devices that have to be replaced with fresh batteries. The company promises a lifetime of up to 15 years, Axionics claims is three times longer than Medtronic’s InterStim. Additionally, it’s 60% smaller. Read more.
Source: Medgadget, February 26, 2019
Scanning the bladder and measuring its volume is a common procedure usually performed by nurses. It may be done for a variety of reasons, but achieving accuracy is key. Catheterization-based methods may be the most accurate, but non-invasive ultrasound is a lot more attractive. With conventional ultrasound one must be very careful to properly gauge the margins of the bladder, then essentially use a ruler on a 3D object, and finish using a formula that really only provides a rough estimate. EchoNous, based in Redmond, Washington, has released a device that lets nurses measure bladder volume faster and with greater confidence, hopefully resulting in more accurate numbers. Read more.
Source: Medgadget, February 20, 2019
The Food and Drug Administration (FDA) has granted Fast Track designation to RDD-0315, a novel topical gel for the treatment of fecal incontinence in spinal cord injury patients. RDD-0315 contains the alpha-agonist oxymetazoline in a topical gel formulation; it works by contracting the internal anal sphincter muscle. In a randomized, controlled crossover study involving 19 patients with spinal cord injury, the investigational gel was found to be beneficial, due to the local effect of oxymetazoline; a statistically significant reduction in the number of fecal incontinence episodes was observed 8 hours and 12 hours post-administration. Read more.
Source: MPR, February 15, 2019
Detecting bacterial infestations within the GI system, particularly using low cost methods, takes so much time that treatment is often administered too late. Clostridium difficile (C. diff) is a particular nasty nuisance that kills many frail patients, and even with a hospital lab it can take up to two days to get the results. Researchers at Chinese University of Hong Kong (CUHK) have developed fluorescent microrobots that can spot C. diff in a stool sample within a matter of minutes without relying on expensive laboratory equipment. Read more.
Source: Medgadget, February 15, 2019
With IlliniCare Health holding fast to its drastic cuts to reimbursement for incontinence supplies, ActivStyle has taken a hard a line. In November, the provider—the state’s largest provider of the supplies—announced it would no longer participate in the payer’s network, something it had done since 2011, says CEO Gayle Devin. “After fighting the fight, we made the decision that we can’t continue to operate at a loss here,” she said. “We labored long and hard over the decision, but if pulling out will help our cause (so be it).” IlliniCare, a Medicaid managed care payer, announced across-the-board cuts to DME and supplies of up to 50% in September 2017, effective Jan. 1, 2018. Concessions were made for other product categories, but not incontinence, despite evidence that providing the right products for patients saves money, says Devin. Read more.
Source: HME News, January 30, 2019