Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
November 2019 proved to be a fruitful month for urology-specific FDA approvals, with the agency giving the green light to a new drug for complicated urinary tract infection, an implantable device for the treatment of overactive bladder/retention, and a digital product for strengthening of pelvic floor muscles and treatment of urinary incontinence in women. The FDA approved cefiderocol (FETROJA) in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following: susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Read more.
Source: Urology Times, December 4, 2019
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention. The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. Read more.
Source: Business Wire, November 14 2019
Since 1989, the American College of Surgeons (ACS) has acknowledged individuals who have distinguished themselves through their exemplary investments in the mission of the College and in philanthropy with the Distinguished Philanthropist Award. The Board of Directors of the ACS Foundation will present the 2019 Distinguished Philanthropist Award to Christopher K. Payne, MD, FACS, at its annual Donor Recognition Luncheon Monday. The award recognizes Dr. Payne for his philanthropic endeavors, service to the surgical profession, and long-lasting contributions to the medical community and the ACS. Read more.
Source: American College of Surgeons Clinical Congress News, October 31, 2019
While much of the new product development for adult incontinence today has led to thinner and thinner products for light incontinence, Illinois-based NorthShore Care Supply has focused on bringing innovation and dignity to those who suffer from moderate to heavy incontinence. Witnessing family members struggling to manage their incontinence supplies using traditional retail products is what led Adam Greenberg to start up an adult incontinence business while completing his MBA at the University of Chicago Booth School of Business in 2002. “At that that time, it was very confusing to shop for premium adult diapers online as everything sounded and looked the same and there was nobody that could help guide my family through this frustrating and embarrassing process,” says Greenberg, owner and president of NorthShore Care Supply. “So I studied up, and quickly became a diaper expert and was able to translate all the clinical specifications designed for nurses and hospitals into a very user friendly format that put families and patients at ease and made them feel like our products had a good chance to provide them the dignity and security that they’d been searching for.” Read more.
Source: Nonwovens Industry, October 17, 2019
Axonics announced the presentation of detailed one-year results from its ARTISAN rechargeable sacral neuromodulation (r-SMN) pivotal study at a plenary session at the joint scientific meeting of the American Urogynecologic Society (AUGS) and the International Urogynecological Association (IUGA). The presentation of positive data, as well as numerous launch activities, highlighted Axonics’ first scientific meeting following the US Food and Drug Administration (FDA) clearance of the Axonics r-SNM System1 in September 2019. During the meeting, more than 350 physicians of the approximate 2,000 at the conference, attended a one-hour symposium at which experienced physician implanters from the ARTISAN-SNM pivotal study discussed their first-hand impressions of the Axonics r-SNM System and post-implant patient feedback. Read more.
Source: Neuro News, October 7, 2019
Medtronic plc (MDT) today announced it has filed a pre-market approval (PMA) supplement with the United States Food and Drug Administration (FDA) for approval of its InterStim™ Micro neurostimulator and also its InterStim™ SureScan™ MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan™ leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval. Read more.
Source: Globe Newswire, October 7, 2019
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”). The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia. The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term. Read more.
Source: Business Wire, September 9, 2019